Depression, AnxietyNCT05315648
Effect of General and Non-general Anesthesia on Perioperative Depression or Anxiety
A study testing anesthesia approach (general anesthesia or non-general anesthesia) in people with Depression, Anxiety, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Perioperative depression and/or anxiety play a critical role in patient presentation, satisfaction and outcomes. The aim of this study is to assess the level of perioperative depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their relationship with anesthesia approach (general… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- anesthesia approach (general anesthesia or non-general anesthesia)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be scheduled to receive anterior cruciate ligament reconstruction of knee joint for the first time
- American Society of Anesthesiologists (ASA) physical status I or II
- The operation time is less than 2 hours (from the beginning use of the tourniquet to the release)
Who cannot join
- Clinical diagnosis of anxiety or depression or mania
- Clinical diagnosis of systemic diseases (systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, primary aldosteronism, Cushing syndrome)
- Medication history of cortisol or sedative hypnotic drugs
- Tumor patients
- Smoking
- Pregnancy status
- Diabetes
- Drinking coffee or alcohol drinks during perioperative period
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of WenZhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: The Associations Between Perioperative Depression or Anxiety, Salivary Cortisol and α-amylase, and Administered Anesthesia Type in Knee Arthroscopy With Anterior Cruciate Ligament Reconstruction (ACLR): Prospective, Randomized Trial
Perioperative depression and/or anxiety play a critical role in patient presentation, satisfaction and outcomes. The aim of this study is to assess the level of perioperative depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their relationship with anesthesia approach (general anesthesia or non general anesthesia). The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires and the level of salivary cortisol, salivary α-amylase (sAA) and blood glucose.
Read the detailed description
The incidence of perioperative anxiety has been reported to range from 11% to 80% among adult patients. Perioperative depression and/or anxiety may increase the risk of poor postoperative outcomes including increased morbidity and mortality , increased health care utilization, increased opioid consumptions and pain scores, and decreased quality of recovery. Previous studies have found that worrying about postoperative pain, unease of separation from family, loss of selfcare and work ability, fear of surgery and even death are common factors leading to perioperative anxiety symptoms.
The investigators found there were not enough studies to gain insights into the public's knowledges, attitudes, and concerns regarding the risks associated with anesthesia. To some, the fear of general anesthesia (GA) remains prevalent, especially with regard to possible brain damage, death, and intraoperative awareness. The others, neuraxial anesthesia was supposed to result in potentially complications, including postdural puncture headache, backache, transient neurological symptoms, epidural hematoma and abscess, meningitis, arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity.
Such fears can even exceed the anxiety about actual surgery. Actually, anesthesia approach can be selected based on patients and anesthesiologists preference.
The investigators assumed from clinical experiences that effects of different anesthetic approach and anesthetic drugs on stress reaction, perioperative blood glucose, immunity or neuroendocrine during surgical operation were different, which resulted different prognosis of patients.
The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires, salivary cortisol, salivary α-amylase (sAA) and blood glucose.
Salivary cortisol and a-amylase are produced respectively by the hypothalamus-pituitary-adrenal (HPA) axis and the sympathetic-adrenomedullary (SAM) system during stress response, still not included in the routine evaluation of perioperative physiological stress response. The application of these tests require additional and definitive validation. In our study, salivary cortisol and a-amylase are measured as stress biomarkers to examine their associations with anesthetic approach.The correlation between salivary cortisol and serum cortisol was excellent in dynamic tests of adrenal function (dexamethasone suppression, adreno-cortico-tropic-hormone stimulation), in healthy subjects and in patients with adrenal insufficiency, in tests of circadian variation and in randomly collected samples. The rate of equilibrium of cortisol between blood and saliva was very fast, being less than 5 minutes. Since only free levels of cortisol are detected in saliva, salivary cortisol is suggested to be a more appropriate measure for the clinical assessment of adrenocortical function than serum cortisol. sAA has been proposed as a sensitive biomarker for stress-related changes in the body that reflect the activity of the sympathetic nervous system, and a growing body of research is accumulating to support the validity and reliability of this parameter. Numerous studies applying stress protocols have demonstrated that salivary a-amylase is highly sensitive to stress-related changes.
The investigators are trying to recruit patients who are scheduled to undergo knee arthroscopy with anterior cruciate ligament reconstruction (ACLR) for the first time. Those patients will be randomly assigned to general anesthesia (GA) group or non-general anesthesia (NGA) group. Patients in GA group will received general anesthesia combined with femoral nerve block (FNB). Patients in NGA group will received neuraxial anesthesia combined with FNB, and without sedation. All patients received routine anesthesia and surgical protocols and will be sent to the postoperative recovery unit (PACU) after surgery. Intraoperative vital signs, analgesic usage, and duration of surgery were recorded.
The primary outcomes are HADS scores , salivary cortisol, sAA, blood glucose，swelling ratings postoperatively, temperature ratings postoperatively and hospital stay. Secondary outcomes are analgesic usage intraoperative and postoperative, anesthesia induction pain score, postoperative pain score, duration of stay in the recovery unit, incidences of complications about relevant anesthesia.
The Patients Hospital Anxiety and Depression Scale (HADS), a 14-item scale (7 items each for anxiety and depression), with each item scored from 0 to 3. Salivary cortisol, sAA and blood glucose levels will be tested in the morning one day before operation (T0), on the day of operation (T1), 2 hours after operation (T2), the first morning after operation (T3), the second morning after operation (T4).
The investigators will conduct subgroup analysis based on the patients' anesthesia wishes (conform to patient's wishes, against patient's wishes, no original opinion) to address the influence of anaesthesia practice and perioperative stress response.
- Conditions
- Depression, Anxiety
- Being tested
- anesthesia approach (general anesthesia or non-general anesthesia)
- Keywords
- perioperative anxiety or depression, general anesthesia, salivary cortisol, salivary α-amylase, Hospital Anxiety and Depression Scale, stress response, non-general anesthesia
- Medical subject headings
- Depression, Anxiety Disorders, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia approach (general anesthesia or non-general anesthesia)Procedure or surgery
patients in group GA received general anesthesia followed with FNB. patients in group NGA received CSEA followed with FNB
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | Experimental | Patients in GA group will receive general anesthesia combined with FNB. All patients received routine anesthesia and surgical protocols. GA will be induced by intravenously administering propofol 2-4 mg/kg, cisatracurium 0.2mg/kg, sufentanil 0.2-0.3 μg/kg and maintained with remifentanil at 0.15-0.2 μg/kg/min and 2%-3% sevoflurane to keep bispectral index (BIS) values at 40 - 60. FNB will be performed under ultrasound-guieded and combined with nerve stimulation. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle will be inserted in the lateral to medial direction towards the femoral nerve (FN). As the needle is being advanced toward the FN, the nerve stimulator is set at 1 mA, 0.1-millisecond pulse duration, and 2-Hz frequency. When the muscle contraction of the quadriceps muscle is identified, the current is reduced to 0.5 mA. After the negative aspiration, 20 mL of ropivacaine 0.375% is injected. Receives: Procedure: anesthesia approach (general anesthesia or non-general anesthesia) |
| Non-general anesthesia group | Experimental | Patients in NGA group will receive combined spinal-epidural anesthesia（CSEA）at L3 to L4 interspace with 3.0 ml of 0.5% hyperbaric ropivacaine followed with FNB , and without sedation. The FNB will be performed under aseptic precautions using ultrasound guidance and nerve stimulation. A high frequency linear ultrasound transducer 5-12 MHz (Sonosite, Inc. Bothell WA 98021 USA) was placed on the inguinal crease to identify the femoral artery and nerve. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle connected to the nerve stimulator will be inserted in the lateral to medial direction towards the femoral nerve. When the muscle contraction of the quadriceps muscle and negative aspiration are identified, 20 mL of ropivacaine 0.375% is injected.
If the CSEA analgesia is invalid (two times of epidural remedial analgesia) , change non-general anesthesia to general anesthesia, and the subjects withdrew from the trial. Receives: Procedure: anesthesia approach (general anesthesia or non-general anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Anxiety symptoms (HADS-A)
The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression.
The score for each individual item could vary from 0 to 3, so that the total score for each scale about anxiety (HADS-A) ranges from 0 to 21. If the score was 0-7, indicating that there was no anxiety; the score was 8-10, suspected anxiety; 11-14, moderate anxiety; the score was 15-21, severe anxiety. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.
Measured: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital
The rate of Depression symptoms (HADS-D)
The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression.
The score for each individual item could vary from 0 to 3, so that the total score for each scale about depression (HADS-D) ranges from 0 to 21. If the score was 0-7, indicating that there was no depression; the score was 8-10, suspected depression; 11-14, moderate depression; the score was 15-21, severe depression. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.
Measured: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital
The changes of salivary cortisol concentration
Enzyme immunoassay for the quantitative determination of free Cortisol in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.
Measured: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
The changes of Saliva α- amylase activity
Enzymatic assay for the determination of alpha amylase activity in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.
Measured: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
The changes of Blood glucose level
Using a glucose meter to check and monitor blood sugar via finger stick
Measured: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Secondary outcomes (9)
The changes of swelling rating
The postoperative knee swelling rating on the surgical side is defined as the knee circumference on the surgical side minus the knee circumference on the non-suigical side, both measured in centimeters (cm) at 5.08 cm above the superior border of the patella, 6 h, 12 h, 24 h, 48 h, and 72 h postoperatively. The larger value means more severe swelling after surgery.
Measured: at 6, 12, 24, 48, and 72 hours after surgery
Post-operative opioid consumptions
postoperative opioid consumption including sufentanil consumptions in PACU and the rescue analgesics (morphine 0.05 mg/kg) when NRS > 3. (sufentanil will be converted into morphine equivalents)
Measured: from arrived at PACU to the first 72 post-operative hours
The changes of NRS of postoperative pain
Patients evaluate the pain at rest and on knee flexion after surgery. NRS will be used to assess the intensity of pain, ranged from 0-10, 0 means no pain and 10 means severe pain.
Measured: at 2, 6, 12, 24, 48, and 72 hours after surgery
Complications related to general anesthesia
Number of Participants with the complications relaterd to general anesthesia such as intraoperative hypoxemia, postoperative nausea and vomiting , postoperative deliriums, postoperative cognitive dysfunction in each group
Measured: started from the induction of general anesthesia to the first 72 post-operative hours
Complications related to combined spinal-epidural anesthesia
Number of Participants with the complications relaterd to combined spinal-epidural anesthesia such as postdural puncture headache, backache, transient neurological symptoms, epidural hematoma and abscess, meningitis, arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity and infection in each group
Measured: started from the beginning of combined spinal-epidural anesthesia to the first 72 post-operative hours
Complications related to femoral nerve block
Number of Participants with the complications relaterd to femoral nerve block such as nerve injury, hematoma, local anesthetic systemic toxicity and infection in each group
Measured: started from the puncture of nerve block to the first 72 post-operative hours
Costs of hospitalization
Costs will be calculated about total standardized costs before healthcare coverage，such as social medical reimbursement or health insurance.Costs will be evaluated in 2022 renminbi (RMB) yuans.
Measured: through study completion, an average of 1 week
The changes of skin temperature rating
Skin temperature of the knee is measured at the center of the anterior patella on postoperative days 1, 3, and 5. Limbs will be exposed to room temperature for 5 minutes bilaterally and then the skin temperature was measured with a skin temperature gun. The skin temperature on the surgical side was defined as the skin temperature on the surgical side minus the skin temperature on the unsurgical side, both measured in degrees centigrade (°C) .
Measured: at 1, 3, and 5 days after surgery
Length of hospital stay
from the day when the patients arrived at the ward for reception to the day when the patients discharged, based on the electronic medical record system
Measured: The length of hospital stay was counted in days, about 5 to 7 days usually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start20 Oct 2021
- Primary completion31 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio into two groups, group GA and group NGA, using a random number generator. This allocation will be written and stored in an opaque, secure envelope. Patients in group GA will receive general anesthesia followed by femoral nerve block. Patients in group NGA will receive combined spinal-epidural anesthesia followed by femoral nerve block.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Congcong Huang, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- CongCong Huang, Master, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315648
- Sponsor's protocol ID
- SAHoWMU-CR2021-03-109
- Status last verified
- Jun 2024
- First submitted
- 26 Oct 2021
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khoo B, Boshier PR, Freethy A, Tharakan G, Saeed S, Hill N, Williams EL, Moorthy K, Tolley N, Jiao LR, Spalding D, Palazzo F, Meeran K, Tan T. Redefining the stress cortisol response to surgery. Clin Endocrinol (Oxf). 2017 Nov;87(5):451-458. doi: 10.1111/cen.13439. Epub 2017 Aug 30.
PubMed 28758231Nagase K, Ando-Nagase K. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 2000 Jul;91(1):250. doi: 10.1097/00000539-200007000-00062. No abstract available.
PubMed 10866931Takagi H, Ando T, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels. 2017 Dec;32(12):1458-1468. doi: 10.1007/s00380-017-1022-3. Epub 2017 Jul 13.
PubMed 28702898Dunn LK, Durieux ME, Fernandez LG, Tsang S, Smith-Straesser EE, Jhaveri HF, Spanos SP, Thames MR, Spencer CD, Lloyd A, Stuart R, Ye F, Bray JP, Nemergut EC, Naik BI. Influence of catastrophizing, anxiety, and depression on in-hospital opioid consumption, pain, and quality of recovery after adult spine surgery. J Neurosurg Spine. 2018 Jan;28(1):119-126. doi: 10.3171/2017.5.SPINE1734. Epub 2017 Nov 10.
PubMed 29125426Smith PJ, Snyder LD, Palmer SM, Hoffman BM, Stonerock GL, Ingle KK, Saulino CK, Blumenthal JA. Depression, social support, and clinical outcomes following lung transplantation: a single-center cohort study. Transpl Int. 2018 May;31(5):495-502. doi: 10.1111/tri.13094. Epub 2017 Dec 14.
PubMed 29130541Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
PubMed 11207465Capdevila X, Dadure C. Perioperative management for one day hospital admission: regional anesthesia is better than general anesthesia. Acta Anaesthesiol Belg. 2004;55 Suppl:33-6.
PubMed 15625956Johnson RL, Kopp SL, Burkle CM, Duncan CM, Jacob AK, Erwin PJ, Murad MH, Mantilla CB. Neuraxial vs general anaesthesia for total hip and total knee arthroplasty: a systematic review of comparative-effectiveness research. Br J Anaesth. 2016 Feb;116(2):163-76. doi: 10.1093/bja/aev455.
PubMed 26787787Imbelloni LE, Fornasari M, Fialho JC, Sant'Anna R, Cordeiro JA. General anesthesia versus spinal anesthesia for laparoscopic cholecystectomy. Rev Bras Anestesiol. 2010 May-Jun;60(3):217-27. doi: 10.1016/S0034-7094(10)70030-1.
PubMed 20682154Wu L, Zhao H, Wang T, Pac-Soo C, Ma D. Cellular signaling pathways and molecular mechanisms involving inhalational anesthetics-induced organoprotection. J Anesth. 2014 Oct;28(5):740-58. doi: 10.1007/s00540-014-1805-y. Epub 2014 Mar 9.
PubMed 24610035Edipoglu IS, Celik F. The Associations Between Cognitive Dysfunction, Stress Biomarkers, and Administered Anesthesia Type in Total Knee Arthroplasties: Prospective, Randomized Trial. Pain Physician. 2019 Sep;22(5):495-507.
PubMed 31561651Franks NP. Molecular targets underlying general anaesthesia. Br J Pharmacol. 2006 Jan;147 Suppl 1(Suppl 1):S72-81. doi: 10.1038/sj.bjp.0706441.
PubMed 16402123Chau PL. New insights into the molecular mechanisms of general anaesthetics. Br J Pharmacol. 2010 Sep;161(2):288-307. doi: 10.1111/j.1476-5381.2010.00891.x.
PubMed 20735416Cozma S, Dima-Cozma LC, Ghiciuc CM, Pasquali V, Saponaro A, Patacchioli FR. Salivary cortisol and alpha-amylase: subclinical indicators of stress as cardiometabolic risk. Braz J Med Biol Res. 2017 Feb 6;50(2):e5577. doi: 10.1590/1414-431X20165577.
PubMed 28177057Burke HM, Davis MC, Otte C, Mohr DC. Depression and cortisol responses to psychological stress: a meta-analysis. Psychoneuroendocrinology. 2005 Oct;30(9):846-56. doi: 10.1016/j.psyneuen.2005.02.010.
PubMed 15961250
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations Between Perioperative Depression or Anxiety, Salivary Cortisol and α-amylase, and Administered Anesthesia Type in Knee Arthroscopy With Anterior Cruciate Ligament Reconstruction (ACLR): Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05315648
- Acronym / sponsor ID
- SAHoWMU-CR2021-03-109
- Conditions
- Depression, Anxiety
- Keywords
- perioperative anxiety or depression, general anesthesia, salivary cortisol, salivary α-amylase, Hospital Anxiety and Depression Scale, stress response, non-general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative depression and/or anxiety play a critical role in patient presentation, satisfaction and outcomes. The aim of this study is to assess the level of perioperative depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their relationship with anesthesia approach (general anesthesia or non general anesthesia). The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires and the level of salivary cortisol, salivary α-amylase (sAA) and blood glucose.
Detailed description
The incidence of perioperative anxiety has been reported to range from 11% to 80% among adult patients. Perioperative depression and/or anxiety may increase the risk of poor postoperative outcomes including increased morbidity and mortality , increased health care utilization, increased opioid consumptions and pain scores, and decreased quality of recovery. Previous studies have found that worrying about postoperative pain, unease of separation from family, loss of selfcare and work ability, fear of surgery and even death are common factors leading to perioperative anxiety symptoms.
The investigators found there were not enough studies to gain insights into the public's knowledges, attitudes, and concerns regarding the risks associated with anesthesia. To some, the fear of general anesthesia (GA) remains prevalent, especially with regard to possible brain damage, death, and intraoperative awareness. The others, neuraxial anesthesia was supposed to result in potentially complications, including postdural puncture headache, backache, transient neurological symptoms, epidural hematoma and abscess, meningitis, arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity.
Such fears can even exceed the anxiety about actual surgery. Actually, anesthesia approach can be selected based on patients and anesthesiologists preference.
The investigators assumed from clinical experiences that effects of different anesthetic approach and anesthetic drugs on stress reaction, perioperative blood glucose, immunity or neuroendocrine during surgical operation were different, which resulted different prognosis of patients.
The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires, salivary cortisol, salivary α-amylase (sAA) and blood glucose.
Salivary cortisol and a-amylase are produced respectively by the hypothalamus-pituitary-adrenal (HPA) axis and the sympathetic-adrenomedullary (SAM) system during stress response, still not included in the routine evaluation of perioperative physiological stress response. The application of these tests require additional and definitive validation. In our study, salivary cortisol and a-amylase are measured as stress biomarkers to examine their associations with anesthetic approach.The correlation between salivary cortisol and serum cortisol was excellent in dynamic tests of adrenal function (dexamethasone suppression, adreno-cortico-tropic-hormone stimulation), in healthy subjects and in patients with adrenal insufficiency, in tests of circadian variation and in randomly collected samples. The rate of equilibrium of cortisol between blood and saliva was very fast, being less than 5 minutes. Since only free levels of cortisol are detected in saliva, salivary cortisol is suggested to be a more appropriate measure for the clinical assessment of adrenocortical function than serum cortisol. sAA has been proposed as a sensitive biomarker for stress-related changes in the body that reflect the activity of the sympathetic nervous system, and a growing body of research is accumulating to support the validity and reliability of this parameter. Numerous studies applying stress protocols have demonstrated that salivary a-amylase is highly sensitive to stress-related changes.
The investigators are trying to recruit patients who are scheduled to undergo knee arthroscopy with anterior cruciate ligament reconstruction (ACLR) for the first time. Those patients will be randomly assigned to general anesthesia (GA) group or non-general anesthesia (NGA) group. Patients in GA group will received general anesthesia combined with femoral nerve block (FNB). Patients in NGA group will received neuraxial anesthesia combined with FNB, and without sedation. All patients received routine anesthesia and surgical protocols and will be sent to the postoperative recovery unit (PACU) after surgery. Intraoperative vital signs, analgesic usage, and duration of surgery were recorded.
The primary outcomes are HADS scores , salivary cortisol, sAA, blood glucose，swelling ratings postoperatively, temperature ratings postoperatively and hospital stay. Secondary outcomes are analgesic usage intraoperative and postoperative, anesthesia induction pain score, postoperative pain score, duration of stay in the recovery unit, incidences of complications about relevant anesthesia.
The Patients Hospital Anxiety and Depression Scale (HADS), a 14-item scale (7 items each for anxiety and depression), with each item scored from 0 to 3. Salivary cortisol, sAA and blood glucose levels will be tested in the morning one day before operation (T0), on the day of operation (T1), 2 hours after operation (T2), the first morning after operation (T3), the second morning after operation (T4).
The investigators will conduct subgroup analysis based on the patients' anesthesia wishes (conform to patient's wishes, against patient's wishes, no original opinion) to address the influence of anaesthesia practice and perioperative stress response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio into two groups, group GA and group NGA, using a random number generator. This allocation will be written and stored in an opaque, secure envelope. Patients in group GA will receive general anesthesia followed by femoral nerve block. Patients in group NGA will receive combined spinal-epidural anesthesia followed by femoral nerve block.
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | Experimental | Procedure: anesthesia approach (general anesthesia or non-general anesthesia)Patients in GA group will receive general anesthesia combined with FNB. All patients received routine anesthesia and surgical protocols. GA will be induced by intravenously administering propofol 2-4 mg/kg, cisatracurium 0.2mg/kg, sufentanil 0.2-0.3 μg/kg and maintained with remifentanil at 0.15-0.2 μg/kg/min and 2%-3% sevoflurane to keep bispectral index (BIS) values at 40 - 60. FNB will be performed under ultrasound-guieded and combined with nerve stimulation. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle will be inserted in the lateral to medial direction towards the femoral nerve (FN). As the needle is being advanced toward the FN, the nerve stimulator is set at 1 mA, 0.1-millisecond pulse duration, and 2-Hz frequency. When the muscle contraction of the quadriceps muscle is identified, the current is reduced to 0.5 mA. After the negative aspiration, 20 mL of ropivacaine 0.375% is injected. |
| Non-general anesthesia group | Experimental | Procedure: anesthesia approach (general anesthesia or non-general anesthesia)Patients in NGA group will receive combined spinal-epidural anesthesia（CSEA）at L3 to L4 interspace with 3.0 ml of 0.5% hyperbaric ropivacaine followed with FNB , and without sedation. The FNB will be performed under aseptic precautions using ultrasound guidance and nerve stimulation. A high frequency linear ultrasound transducer 5-12 MHz (Sonosite, Inc. Bothell WA 98021 USA) was placed on the inguinal crease to identify the femoral artery and nerve. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle connected to the nerve stimulator will be inserted in the lateral to medial direction towards the femoral nerve. When the muscle contraction of the quadriceps muscle and negative aspiration are identified, 20 mL of ropivacaine 0.375% is injected. If the CSEA analgesia is invalid (two times of epidural remedial analgesia) , change non-general anesthesia to general anesthesia, and the subjects withdrew from the trial. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants will be scheduled to receive anterior cruciate ligament reconstruction of knee joint for the first time
- American Society of Anesthesiologists (ASA) physical status I or II
- The operation time is less than 2 hours (from the beginning use of the tourniquet to the release)
Key exclusion criteria (8 listed)
- Clinical diagnosis of anxiety or depression or mania
- Clinical diagnosis of systemic diseases (systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, primary aldosteronism, Cushing syndrome)
- Medication history of cortisol or sedative hypnotic drugs
- Tumor patients
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesia approach (general anesthesia or non-general anesthesia)patients in group GA received general anesthesia followed with FNB. patients in group NGA received CSEA followed with FNB | Procedure or surgery | General anesthesia group, Non-general anesthesia group |
Primary outcome
The rate of Anxiety symptoms (HADS-A)
Time frame: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital
The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression. The score for each individual item could vary from 0 to 3, so that the total score for each scale about anxiety (HADS-A) ranges from 0 to 21. If the score was 0-7, indicating that there was no anxiety; the score was 8-10, suspected anxiety; 11-14, moderate anxiety; the score was 15-21, severe anxiety. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.
The rate of Depression symptoms (HADS-D)
Time frame: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital
The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression. The score for each individual item could vary from 0 to 3, so that the total score for each scale about depression (HADS-D) ranges from 0 to 21. If the score was 0-7, indicating that there was no depression; the score was 8-10, suspected depression; 11-14, moderate depression; the score was 15-21, severe depression. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.
The changes of salivary cortisol concentration
Time frame: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Enzyme immunoassay for the quantitative determination of free Cortisol in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.
The changes of Saliva α- amylase activity
Time frame: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Enzymatic assay for the determination of alpha amylase activity in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.
The changes of Blood glucose level
Time frame: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Using a glucose meter to check and monitor blood sugar via finger stick
9 secondary outcomes
The changes of swelling rating
Time frame: at 6, 12, 24, 48, and 72 hours after surgery
Post-operative opioid consumptions
Time frame: from arrived at PACU to the first 72 post-operative hours
The changes of NRS of postoperative pain
Time frame: at 2, 6, 12, 24, 48, and 72 hours after surgery
Complications related to general anesthesia
Time frame: started from the induction of general anesthesia to the first 72 post-operative hours
Complications related to combined spinal-epidural anesthesia
Time frame: started from the beginning of combined spinal-epidural anesthesia to the first 72 post-operative hours
Complications related to femoral nerve block
Time frame: started from the puncture of nerve block to the first 72 post-operative hours
Costs of hospitalization
Time frame: through study completion, an average of 1 week
The changes of skin temperature rating
Time frame: at 1, 3, and 5 days after surgery
Length of hospital stay
Time frame: The length of hospital stay was counted in days, about 5 to 7 days usually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 28758231Khoo B, Boshier PR, Freethy A, Tharakan G, Saeed S, Hill N, Williams EL, Moorthy K, Tolley N, Jiao LR, Spalding D, Palazzo F, Meeran K, Tan T. Redefining the stress cortisol response to surgery. Clin Endocrinol (Oxf). 2017 Nov;87(5):451-458. doi: 10.1111/cen.13439. Epub 2017 Aug 30.
- Background: PubMed 10866931Nagase K, Ando-Nagase K. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 2000 Jul;91(1):250. doi: 10.1097/00000539-200007000-00062. No abstract available.
- Background: PubMed 28702898Takagi H, Ando T, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels. 2017 Dec;32(12):1458-1468. doi: 10.1007/s00380-017-1022-3. Epub 2017 Jul 13.
- Background: PubMed 29125426Dunn LK, Durieux ME, Fernandez LG, Tsang S, Smith-Straesser EE, Jhaveri HF, Spanos SP, Thames MR, Spencer CD, Lloyd A, Stuart R, Ye F, Bray JP, Nemergut EC, Naik BI. Influence of catastrophizing, anxiety, and depression on in-hospital opioid consumption, pain, and quality of recovery after adult spine surgery. J Neurosurg Spine. 2018 Jan;28(1):119-126. doi: 10.3171/2017.5.SPINE1734. Epub 2017 Nov 10.
- Background: PubMed 29130541Smith PJ, Snyder LD, Palmer SM, Hoffman BM, Stonerock GL, Ingle KK, Saulino CK, Blumenthal JA. Depression, social support, and clinical outcomes following lung transplantation: a single-center cohort study. Transpl Int. 2018 May;31(5):495-502. doi: 10.1111/tri.13094. Epub 2017 Dec 14.
- Background: PubMed 11207465Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
- Background: PubMed 15625956Capdevila X, Dadure C. Perioperative management for one day hospital admission: regional anesthesia is better than general anesthesia. Acta Anaesthesiol Belg. 2004;55 Suppl:33-6.
- Background: PubMed 26787787Johnson RL, Kopp SL, Burkle CM, Duncan CM, Jacob AK, Erwin PJ, Murad MH, Mantilla CB. Neuraxial vs general anaesthesia for total hip and total knee arthroplasty: a systematic review of comparative-effectiveness research. Br J Anaesth. 2016 Feb;116(2):163-76. doi: 10.1093/bja/aev455.
- Background: PubMed 20682154Imbelloni LE, Fornasari M, Fialho JC, Sant'Anna R, Cordeiro JA. General anesthesia versus spinal anesthesia for laparoscopic cholecystectomy. Rev Bras Anestesiol. 2010 May-Jun;60(3):217-27. doi: 10.1016/S0034-7094(10)70030-1.
- Background: PubMed 24610035Wu L, Zhao H, Wang T, Pac-Soo C, Ma D. Cellular signaling pathways and molecular mechanisms involving inhalational anesthetics-induced organoprotection. J Anesth. 2014 Oct;28(5):740-58. doi: 10.1007/s00540-014-1805-y. Epub 2014 Mar 9.
- Background: PubMed 31561651Edipoglu IS, Celik F. The Associations Between Cognitive Dysfunction, Stress Biomarkers, and Administered Anesthesia Type in Total Knee Arthroplasties: Prospective, Randomized Trial. Pain Physician. 2019 Sep;22(5):495-507.
- Background: PubMed 16402123Franks NP. Molecular targets underlying general anaesthesia. Br J Pharmacol. 2006 Jan;147 Suppl 1(Suppl 1):S72-81. doi: 10.1038/sj.bjp.0706441.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CongCong Huang, Master study director
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthesia approach (general anesthesia or non-general anesthesia) in people with Depression, Anxiety, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of Anxiety symptoms (HADS-A) (time frame: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315648, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.