Anesthesia Recovery PeriodNCT06207344
The Anesthesia Effects of Dexmedetomidine Combined With Desflurane or Propofol in Lobectomy
A study testing Dexmedetomidine and propofol and Dexmedetomidine and desflurane in people with Anesthesia Recovery Period and Postoperative Complications, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
In one-lung ventilation surgery, compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane may be beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Recovery Period, Postoperative Complications
- What is being tested?
- Dexmedetomidine and propofol and Dexmedetomidine and desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 21 Oct 2023to 30 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective thoracoscopic unilateral lobectomy.
- General anesthesia is required and the expected duration of one-lung ventilation is ≥ 1h.
- American Association of Anesthesiologists (ASA) physical condition classification I-III.
- Patients over 18 years old.
- Voluntary participation and ability to understand and sign the informed consent.
Who cannot join
- Obese patients (BMI>28 kg/m2).
- patients with grade 3 hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg).
- Acute coronary syndrome, sinus bradycardia (heart rate < 45 beats/min), II or III degree atrioventricular block, NYHA heart function classification III or IV.
- Patients with severe history of chronic obstructive pulmonary disease (GOLD grade III or IV of pulmonary function of chronic obstructive pulmonary disease), severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis and thoracic deformity.
- Pulmonary artery pressure ≥60 mmHg.
- Patients with Child grade B or C of liver function.
Show all 12Show fewer
- Patients with chronic kidney disease in stage 4 or 5.
- Patients with hyperthyroidism and pheochromocytoma.
- Patients who are expected to need mechanical ventilation after operation.
- People with hearing, intelligence, communication and cognitive impairment.
- For any reason, it is impossible to cooperate with the study or the researcher thinks that it is not suitable to be included in this experiment.
- patients who are expected to be transferred to ICU after operation.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
bing chen, PhD, 86 023 62887913, chengbing@cqmu.edu.cn
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
yupei chen, bachelor, 8602362887913, cypgxhcj@tom.com
About this study
Official title: The Anesthesia Effects of Dexmedetomidine Combined With Desflurane or Propofol in Lobectomy.
In one-lung ventilation surgery, compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane may be beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting.
Read the detailed description
With the increase in the prevalence of lung cancer in recent years, the number of patients undergoing lobectomy has also increased. When performing lobectomy, inserting a double-lumen endotracheal tube or bronchial occlusive device and then ventilating the healthy lung is necessary. The affected lung is not ventilated; that is one-lung ventilation, which can fully expose the vision of the affected lung, provide space for surgical operation, and simultaneously avoid the pollution of the healthy lung. The emergence of one-lung ventilation has extensively promoted the development of thoracic surgery. However, during one-lung ventilation, the affected lung is not ventilated, and the blood flow of the affected lung is not oxygenated, which leads to increased intrapulmonary shunt and hypoxemia. Repeated and excessive inflation of the healthy lung may release many inflammatory factors, trigger local or systemic inflammatory reactions, and increase postoperative pulmonary complications. Therefore, it is an essential goal of anesthesia management to quickly wake up and resume spontaneous breathing to reduce mechanical ventilation time.
Propofol-based intravenous anesthesia and inhalation anesthesia with sevoflurane, isoflurane, or desflurane are clinics' most commonly used general anesthesia methods. It is found that inhalation anesthesia with desflurane is superior to propofol-based intravenous anesthesia in the aspects of eye-opening time, spontaneous breathing recovery time, and extubation time in outpatient surgery, lung volume reduction surgery, lung cancer surgery, and endoscopic lumbar disc surgery. In addition, several meta-analyses found that inhalation anesthesia has an anti-inflammatory effect compared with propofol-based anesthesia, which can reduce alveolar inflammatory reaction and postoperative pulmonary complications in patients with one-lung ventilation. Kawanishi et al. found that desflurane inhalation anesthesia can promote the collapse of the affected lung, shorten the operation time, and reduce the occurrence of atelectasis compared with propofol-based intravenous anesthesia. These studies show that inhalation anesthesia with desflurane is superior to propofol-based intravenous anesthesia in one-lung ventilation surgery.
However, inhalation anesthesia is not perfect, and studies have also found that inhalation anesthesia increases the incidences of restlessness during awakening and postoperative nausea and vomiting. One study found that the incidences of delirium, nausea and vomiting in the desflurane anesthesia group were 50% and 37.5% respectively, while that in the propofol-based intravenous anesthesia group was 10% and 17.5% respectively in lung cancer surgery. Therefore, it is necessary to explore an anesthesia management method that will not affect the advantages of inhalation anesthesia but also reduce the disadvantages of inhalation anesthesia.
Dexmedetomidine is a highly selective α2- adrenergic receptor agonist. Its primary function is sedation, often used as an anesthetic adjuvant. Studies have found that dexmedetomidine can significantly reduce the incidences of delirium during recovery and postoperative nausea and vomiting. In patients undergoing nasal surgery, dexmedetomidine can reduce the incidence of delirium in patients receiving desflurane anesthesia from 52.8% to 5.6%, even lower than the incidence of delirium (10%) in patients receiving propofol in lung cancer surgery. In patients undergoing laparoscopic hysterectomy, the use of dexmedetomidine can reduce the incidence of nausea and vomiting after desflurane anesthesia from 32% to 13%, even lower than that after propofol anesthesia in lung cancer surgery (17.5%). In addition, dexmedetomidine can reduce inflammatory reactions, improve oxidative stress and respiratory mechanics, reduce intrapulmonary shunt, improve oxygenation, and reduce postoperative pulmonary complications in one-lung ventilation surgery. Although dexmedetomidine has a sedative effect, this sedative effect can be awakened easily. Moreover, a meta-analysis found that dexmedetomidine did not prolong the stay time in the anesthesia recovery room but only prolonged extubation time statistically, and it had no clinical significance. In a word, a large number of meta-analyses found that dexmedetomidine can not only reduce the incidence of various adverse events after operation but also has no noticeable effect on patients' recovery.
Therefore, the investigators speculate that compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane is beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting.
- Being tested
- Dexmedetomidine and propofol, Dexmedetomidine and desflurane
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine and propofolDrug
Also called Dexmedetomidine Hydrochloride injection and propofol injectable emulsion
Group 1: After anesthesia induction, dexmedetomidine was infused at 1 μg/kg intravenously within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. Meantime, propofol was infused at 4-12mg/kg/h intravenously to maintain the depth of anesthesia.
Dexmedetomidine and desfluraneDrug
Also called Dexmedetomidine Hydrochloride injection and Suprane
Group 2: After anesthesia induction, dexmedetomidine was infused at 1 μg/kg intravenously within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. At the same time, 2.5%-8.5% desflurane was inhaled to maintain the depth of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine and propofol | Active comparator | After anesthesia induction, dexmedetomidine was infused intravenously at 1 μg/kg within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. Propofol was infused intravenously at 4-12mg/kg/h to maintain the depth of anesthesia (patient state index between 25-50 monitored by Masimo SedLine). Receives: Drug: Dexmedetomidine and propofol |
| Dexmedetomidine and desflurane | Experimental | After anesthesia induction, dexmedetomidine was infused intravenously at 1 μg/kg within 15 min, and then infused at 0.3 μg/kg/h until 30 min before the end of the operation. At the same time, 2.5%-8.5% desflurane was used to maintain the depth of anesthesia (patient state index between 25-50 monitored by Masimo SedLine). Receives: Drug: Dexmedetomidine and desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to open eyes after anesthetics withdrawal
The first time to open eyes after anesthetics withdrawal.
Measured: From time of anesthetic withdrawal to the first time of the patient open his or her eyes, assessed up to 2 hour.
Secondary outcomes (14)
Incidence of delirium
The Richmond Agitation-Sedation Scale (RASS) will be used to assess the incidence of delirium. RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 [combative]), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5). The scores of +2, +3, and +4 are defined as delirium.
Measured: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Incidence of nausea and vomiting
The severity of nausea and vomiting will be evaluated by visual analogue scale (VAS): a 10 cm ruler was used as a scale, one end (0 points) indicated no nausea and vomiting, and the other end was 10 cm, indicating the most severe nausea and vomiting that was unbearable (1~4 was mild, 5~6 was moderate, and 7~10 was severe).
Measured: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Pain level
Numeric Rating Scale will be used to assess the degree of pain. 0~10 is used to represent different degrees of pain: 0 is no pain, 1~3 is mild pain (the pain does not affect sleep), 4~6 is moderate pain (mildly affects sleep), 7~9 is severe pain (unable to fall asleep or wakes up from sleep), and 10 is severe pain.
Measured: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Incidences of other side effects
Any unquestioned side effects will be recorded, such non-planned intensive care unit transfer, unplanned reoperation, unplanned reintubation, etc.
Measured: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Drugs and their dosage
These drugs and their dosage will be recorded, such as muscle relaxant antagonism, antiemetic drugs, and analgesic drugs.
Measured: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
QoR-40 scores
QoR-40 scores will be used to assess the quality of recovery. The questionnaire consists of five subscales: emotional status (9 items), physical comfort (12 items), psychological support (7 items), physical independence (5 items), and pain (7 items). All the items are rated on a five-point scale ranging from 1 to 5. The initial point and conversion score of each item are calculated. Depending on the question, the best answers may have a score of either 5 or 1. The best answers to positive questions are scored 5, while the best answers to negative questions are assigned the score of 1. The total score of QoR-40 is given by the summation of scores for all items and ranges from 40 to 200. The higher the score, the better is the health status.Citation
Measured: Postoperative day 1 and 3.
Postoperative pulmonary complications
The incidence of postoperative pulmonary complications was assessed according to the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) definition. The severity of postoperative pulmonary complications was scored on a 0-5 scale.
Measured: First 7 postoperative days
White blood cell count
White blood cell count will be used to assess the inflammatory level.
Measured: Postoperative day 1 and 3.
Neutrophil ratio
Neutrophil ratio will be used to assess the inflammatory level.
Measured: Postoperative day 1 and 3.
Lymphocyte ratio
Lymphocyte ratio will be used to assess the inflammatory level.
Measured: Postoperative day 1 and 3.
C-reactive protein
C-reactive protein will be used to assess the inflammatory level.
Measured: Postoperative day 1 and 3.
Time for tidal volume of spontaneous breathing over 300 ml
Time from anesthetics withdrawal to tidal volume of spontaneous breathing over 300 ml.
Measured: From time of anesthetic withdrawal to the patient tidal volume of spontaneous breathing over 300 ml, assessed up to 2 hour.
Extubation time
Time from anesthetics withdrawal to extubation
Measured: From time of anesthetic withdrawal to the tracheal tube was extubated, assessed up to 2 hour.
Postanesthesia care unit residence time
Time of staying in postanesthesia care unit
Measured: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start21 Oct 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Recovery PeriodStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Chen, Ph.D, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Bing Chen, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207344
- Sponsor's protocol ID
- 2023.159
- Status last verified
- Mar 2024
- First submitted
- 26 Oct 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available with the responding author when required.
Publications
Campos JH, Feider A. Hypoxia During One-Lung Ventilation-A Review and Update. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2330-2338. doi: 10.1053/j.jvca.2017.12.026. Epub 2017 Dec 19. No abstract available.
PubMed 29361458Bernasconi F, Piccioni F. One-lung ventilation for thoracic surgery: current perspectives. Tumori. 2017 Nov 23;103(6):495-503. doi: 10.5301/tj.5000638. Epub 2017 Jun 7.
PubMed 28604996Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x.
PubMed 9689269Abe K, Shimizu T, Takashina M, Shiozaki H, Yoshiya I. The effects of propofol, isoflurane, and sevoflurane on oxygenation and shunt fraction during one-lung ventilation. Anesth Analg. 1998 Nov;87(5):1164-9. doi: 10.1097/00000539-199811000-00035.
PubMed 9806702Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x.
PubMed 28100177Kawanishi R, Kakuta N, Sakai Y, Hari Y, Sasaki H, Sekiguchi R, Tanaka K. Desflurane improves lung collapse more than propofol during one-lung ventilation and reduces operation time in lobectomy by video-assisted thoracic surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 29;22(1):125. doi: 10.1186/s12871-022-01669-7.
PubMed 35488195Yuan JL, Kang K, Li B, Lu J, Miao MR, Kang X, Zhang JQ, Zhang W. The Effects of Sevoflurane vs. Propofol for Inflammatory Responses in Patients Undergoing Lung Resection: A Meta-Analysis of Randomized Controlled Trials. Front Surg. 2021 Jul 2;8:692734. doi: 10.3389/fsurg.2021.692734. eCollection 2021.
PubMed 34277696Jannu V, Dhorigol MG. Effect of Intraoperative Dexmedetomidine on Postoperative Pain and Pulmonary Function Following Video-assisted Thoracoscopic Surgery. Anesth Essays Res. 2020 Jan-Mar;14(1):68-71. doi: 10.4103/aer.AER_9_20. Epub 2020 Mar 16.
PubMed 32843795Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870.
PubMed 35510198Xia R, Xu J, Yin H, Wu H, Xia Z, Zhou D, Xia ZY, Zhang L, Li H, Xiao X. Intravenous Infusion of Dexmedetomidine Combined Isoflurane Inhalation Reduces Oxidative Stress and Potentiates Hypoxia Pulmonary Vasoconstriction during One-Lung Ventilation in Patients. Mediators Inflamm. 2015;2015:238041. doi: 10.1155/2015/238041. Epub 2015 Jul 26.
PubMed 26273134
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anesthesia Effects of Dexmedetomidine Combined With Desflurane or Propofol in Lobectomy.
- ClinicalTrials.gov ID
- NCT06207344
- Acronym / sponsor ID
- 2023.159
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Jan 2024 (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.
In one-lung ventilation surgery, compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane may be beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting.
Detailed description
With the increase in the prevalence of lung cancer in recent years, the number of patients undergoing lobectomy has also increased. When performing lobectomy, inserting a double-lumen endotracheal tube or bronchial occlusive device and then ventilating the healthy lung is necessary. The affected lung is not ventilated; that is one-lung ventilation, which can fully expose the vision of the affected lung, provide space for surgical operation, and simultaneously avoid the pollution of the healthy lung. The emergence of one-lung ventilation has extensively promoted the development of thoracic surgery. However, during one-lung ventilation, the affected lung is not ventilated, and the blood flow of the affected lung is not oxygenated, which leads to increased intrapulmonary shunt and hypoxemia. Repeated and excessive inflation of the healthy lung may release many inflammatory factors, trigger local or systemic inflammatory reactions, and increase postoperative pulmonary complications. Therefore, it is an essential goal of anesthesia management to quickly wake up and resume spontaneous breathing to reduce mechanical ventilation time.
Propofol-based intravenous anesthesia and inhalation anesthesia with sevoflurane, isoflurane, or desflurane are clinics' most commonly used general anesthesia methods. It is found that inhalation anesthesia with desflurane is superior to propofol-based intravenous anesthesia in the aspects of eye-opening time, spontaneous breathing recovery time, and extubation time in outpatient surgery, lung volume reduction surgery, lung cancer surgery, and endoscopic lumbar disc surgery. In addition, several meta-analyses found that inhalation anesthesia has an anti-inflammatory effect compared with propofol-based anesthesia, which can reduce alveolar inflammatory reaction and postoperative pulmonary complications in patients with one-lung ventilation. Kawanishi et al. found that desflurane inhalation anesthesia can promote the collapse of the affected lung, shorten the operation time, and reduce the occurrence of atelectasis compared with propofol-based intravenous anesthesia. These studies show that inhalation anesthesia with desflurane is superior to propofol-based intravenous anesthesia in one-lung ventilation surgery.
However, inhalation anesthesia is not perfect, and studies have also found that inhalation anesthesia increases the incidences of restlessness during awakening and postoperative nausea and vomiting. One study found that the incidences of delirium, nausea and vomiting in the desflurane anesthesia group were 50% and 37.5% respectively, while that in the propofol-based intravenous anesthesia group was 10% and 17.5% respectively in lung cancer surgery. Therefore, it is necessary to explore an anesthesia management method that will not affect the advantages of inhalation anesthesia but also reduce the disadvantages of inhalation anesthesia.
Dexmedetomidine is a highly selective α2- adrenergic receptor agonist. Its primary function is sedation, often used as an anesthetic adjuvant. Studies have found that dexmedetomidine can significantly reduce the incidences of delirium during recovery and postoperative nausea and vomiting. In patients undergoing nasal surgery, dexmedetomidine can reduce the incidence of delirium in patients receiving desflurane anesthesia from 52.8% to 5.6%, even lower than the incidence of delirium (10%) in patients receiving propofol in lung cancer surgery. In patients undergoing laparoscopic hysterectomy, the use of dexmedetomidine can reduce the incidence of nausea and vomiting after desflurane anesthesia from 32% to 13%, even lower than that after propofol anesthesia in lung cancer surgery (17.5%). In addition, dexmedetomidine can reduce inflammatory reactions, improve oxidative stress and respiratory mechanics, reduce intrapulmonary shunt, improve oxygenation, and reduce postoperative pulmonary complications in one-lung ventilation surgery. Although dexmedetomidine has a sedative effect, this sedative effect can be awakened easily. Moreover, a meta-analysis found that dexmedetomidine did not prolong the stay time in the anesthesia recovery room but only prolonged extubation time statistically, and it had no clinical significance. In a word, a large number of meta-analyses found that dexmedetomidine can not only reduce the incidence of various adverse events after operation but also has no noticeable effect on patients' recovery.
Therefore, the investigators speculate that compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane is beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine and propofol | Active comparator | Drug: Dexmedetomidine and propofolAfter anesthesia induction, dexmedetomidine was infused intravenously at 1 μg/kg within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. Propofol was infused intravenously at 4-12mg/kg/h to maintain the depth of anesthesia (patient state index between 25-50 monitored by Masimo SedLine). |
| Dexmedetomidine and desflurane | Experimental | Drug: Dexmedetomidine and desfluraneAfter anesthesia induction, dexmedetomidine was infused intravenously at 1 μg/kg within 15 min, and then infused at 0.3 μg/kg/h until 30 min before the end of the operation. At the same time, 2.5%-8.5% desflurane was used to maintain the depth of anesthesia (patient state index between 25-50 monitored by Masimo SedLine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective thoracoscopic unilateral lobectomy.
- General anesthesia is required and the expected duration of one-lung ventilation is ≥ 1h.
- American Association of Anesthesiologists (ASA) physical condition classification I-III.
- Patients over 18 years old.
- Voluntary participation and ability to understand and sign the informed consent.
Key exclusion criteria (12 listed)
- Obese patients (BMI>28 kg/m2).
- patients with grade 3 hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg).
- Acute coronary syndrome, sinus bradycardia (heart rate < 45 beats/min), II or III degree atrioventricular block, NYHA heart function classification III or IV.
- Patients with severe history of chronic obstructive pulmonary disease (GOLD grade III or IV of pulmonary function of chronic obstructive pulmonary disease), severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis and thoracic deformity.
- Pulmonary artery pressure ≥60 mmHg.
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 |
|---|---|---|
| Dexmedetomidine and propofolAlso: Dexmedetomidine Hydrochloride injection and propofol injectable emulsionGroup 1: After anesthesia induction, dexmedetomidine was infused at 1 μg/kg intravenously within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. Meantime, propofol was infused at 4-12mg/kg/h intravenously to maintain the depth of anesthesia. | Drug | Dexmedetomidine and propofol |
| Dexmedetomidine and desfluraneAlso: Dexmedetomidine Hydrochloride injection and SupraneGroup 2: After anesthesia induction, dexmedetomidine was infused at 1 μg/kg intravenously within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. At the same time, 2.5%-8.5% desflurane was inhaled to maintain the depth of anesthesia. | Drug | Dexmedetomidine and desflurane |
Primary outcome
Time to open eyes after anesthetics withdrawal
Time frame: From time of anesthetic withdrawal to the first time of the patient open his or her eyes, assessed up to 2 hour.
The first time to open eyes after anesthetics withdrawal.
14 secondary outcomes
Incidence of delirium
Time frame: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Incidence of nausea and vomiting
Time frame: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Pain level
Time frame: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Incidences of other side effects
Time frame: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Drugs and their dosage
Time frame: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
QoR-40 scores
Time frame: Postoperative day 1 and 3.
Postoperative pulmonary complications
Time frame: First 7 postoperative days
White blood cell count
Time frame: Postoperative day 1 and 3.
Neutrophil ratio
Time frame: Postoperative day 1 and 3.
Lymphocyte ratio
Time frame: Postoperative day 1 and 3.
C-reactive protein
Time frame: Postoperative day 1 and 3.
Time for tidal volume of spontaneous breathing over 300 ml
Time frame: From time of anesthetic withdrawal to the patient tidal volume of spontaneous breathing over 300 ml, assessed up to 2 hour.
Extubation time
Time frame: From time of anesthetic withdrawal to the tracheal tube was extubated, assessed up to 2 hour.
Postanesthesia care unit residence time
Time frame: From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 29361458Campos JH, Feider A. Hypoxia During One-Lung Ventilation-A Review and Update. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2330-2338. doi: 10.1053/j.jvca.2017.12.026. Epub 2017 Dec 19. No abstract available.
- Background: PubMed 28604996Bernasconi F, Piccioni F. One-lung ventilation for thoracic surgery: current perspectives. Tumori. 2017 Nov 23;103(6):495-503. doi: 10.5301/tj.5000638. Epub 2017 Jun 7.
- Background: PubMed 9689269Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x.
- Background: PubMed 9806702Abe K, Shimizu T, Takashina M, Shiozaki H, Yoshiya I. The effects of propofol, isoflurane, and sevoflurane on oxygenation and shunt fraction during one-lung ventilation. Anesth Analg. 1998 Nov;87(5):1164-9. doi: 10.1097/00000539-199811000-00035.
- Background: PubMed 28100177Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x.
- Background: PubMed 35488195Kawanishi R, Kakuta N, Sakai Y, Hari Y, Sasaki H, Sekiguchi R, Tanaka K. Desflurane improves lung collapse more than propofol during one-lung ventilation and reduces operation time in lobectomy by video-assisted thoracic surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 29;22(1):125. doi: 10.1186/s12871-022-01669-7.
- Background: PubMed 34277696Yuan JL, Kang K, Li B, Lu J, Miao MR, Kang X, Zhang JQ, Zhang W. The Effects of Sevoflurane vs. Propofol for Inflammatory Responses in Patients Undergoing Lung Resection: A Meta-Analysis of Randomized Controlled Trials. Front Surg. 2021 Jul 2;8:692734. doi: 10.3389/fsurg.2021.692734. eCollection 2021.
- Background: PubMed 32843795Jannu V, Dhorigol MG. Effect of Intraoperative Dexmedetomidine on Postoperative Pain and Pulmonary Function Following Video-assisted Thoracoscopic Surgery. Anesth Essays Res. 2020 Jan-Mar;14(1):68-71. doi: 10.4103/aer.AER_9_20. Epub 2020 Mar 16.
- Background: PubMed 35510198Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870.
- Background: PubMed 26273134Xia R, Xu J, Yin H, Wu H, Xia Z, Zhou D, Xia ZY, Zhang L, Li H, Xiao X. Intravenous Infusion of Dexmedetomidine Combined Isoflurane Inhalation Reduces Oxidative Stress and Potentiates Hypoxia Pulmonary Vasoconstriction during One-Lung Ventilation in Patients. Mediators Inflamm. 2015;2015:238041. doi: 10.1155/2015/238041. Epub 2015 Jul 26.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available with the responding author when required.
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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.
Bing Chen principal investigator
The Second Affiliated Hospital of Chongqing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and propofol and Dexmedetomidine and desflurane in people with Anesthesia Recovery Period and Postoperative Complications, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Chen (8602362887913, cypgxhcj@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to open eyes after anesthetics withdrawal (time frame: From time of anesthetic withdrawal to the first time of the patient open his or her eyes, assessed up to 2 hour.). 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 NCT06207344, which also lists 10 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 13 Mar 2024.