Quality of RecoveryNCT05529875
Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery in Obese Patients
A study testing Propofol and sevoflurane in people with Quality of Recovery, run by Jiangang Song at 1 site in China.
Trial summary
This study was designed to compare propofol intravenous anesthesia to sevoflurane inhalation anesthesia on the quality of recovery after surgery for anal fistula in obese patients. Propofol-based total intravenous anesthesia (TIVA) and sevoflurane inhalation anesthesia are the two main anesthesia techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- Propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Oct 2022to Mar 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
- Patients undergoing selective surgery for anal fistula,
- aged 18-60 years,
- body mass index >30kg/m2,
- patient who required general anesthesia and signed informed consent,
- ASA I - II.
Who cannot join
- patients refused to participate in the test,
- patients with severe cardiac, pulmonary, liver and renal dysfunction,
- patients with severe central nervous system diseases or severe mental diseases,
- patients with a history of alcoholism,
- allergy to related anesthetics,
- pregnant or lactating women,
Show all 9Show fewer
- participated in the other trials in the past month,
- taking any sedative, opioid, or sleep aid drugs,
- patients with other special conditions not suitable for this study, ____________________________________________.
Trial locations and contacts
1 site in 1 country.
China1 site
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203
About this study
Official title: Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery for Anal Fistula in Obese Patients: A Prospective, Randomized, Single-blinded, Controlled Clinical Trial
This study was designed to compare propofol intravenous anesthesia to sevoflurane inhalation anesthesia on the quality of recovery after surgery for anal fistula in obese patients. Propofol-based total intravenous anesthesia (TIVA) and sevoflurane inhalation anesthesia are the two main anesthesia techniques. Obesity influences not only anesthetics metabolic but also physical function of patients, so it is meaningful to study which anesthesia technique is better for the recovery of obese patients after surgery.
Read the detailed description
This study was approved by Ethical Committee of ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese Medicine. Patients were given informed consent before enrolling the study, whereafter, they were randomized into two groups, propofol-based total intravenous anesthesia (Group PRO) and sevoflurane inhalation anesthesia (Group SEVO). After entering the routine, blood pressure, pulse oxygen saturation, and ECG were monitored by multifunctional anesthesia monitor and anesthesia depth was monitored by brain electrical bispectral index (BIS). Intravenous access (20-gauge catheter) was established and an infusion of lactated Ringer's solution began in the operating room. Patients were positioned as left or right lateral decubitus position according to surgery. Patients inhaled oxygen before anesthetic induction using a face mask. Intravenous penehyclidine hydrochloride 0.5mg, granisetron 3mg, and midazolam 2mg were given as premedication.
In Group PRO, anesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg, until the patient loses consciousness, then laryngeal mask airway was inserted. Anesthesia was then maintained with propofol in TCI 3-4ug/kg, if the patient showed body movement, TCI was raised by 0.5 ug/kg every time, until the anesthesia depth was satisfied (no body movement, BIS40-60).
In Group SEVO, anesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane. Firstly, mask was fixed with four head band, keeping it sealed. The method of vital capacity was used, taking deep breaths until the patient loses consciousness (call patients not to answer, the eyelash reflex disappeared, BIS40-60): close valve of APL to zero, empty the breathing bag, block the respiratory circuit, prime the circuit with 8% sevoflurane in O2 at 8 L/min until the inspired-limb drug concentration measured upon 6%. Then, laryngeal mask airway was inserted. Anesthesia was then maintained with sevoflurane, adjusting the oxygen flow rate to 2L/min and sevoflurane vaporizer concentration 1.5-2%, if the patient showed body movement and other narcotic lighter sign, sevoflurane vaporizer concentration was raised by 0.5% every time, until the anesthesia depth was satisfied (no body movement, BIS40-60).
The propofol and sevoflurane were closed at the end of surgery.
Quality of recovery was assessed using QoR-40 scale in day 1 and day 2 after surgery. Postoperative pain intensity was assessed using visual analogue scale in day 1 and day 2 after surgery. Surgical and waking time was recorded before leaving post-anesthesia care unit. Adverse events (circulation or respiratory depression, postoperative nausea and vomiting, recovery agitation) were recorded perioperatively.
- Conditions
- Quality of Recovery
- Being tested
- Propofol, sevoflurane
- Keywords
- propofol, sevoflurane, obese, quality of recovery, anal fistula
- Medical subject headings
- Obesity, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Group PRO
intravenous propofol using target-controlled infusion (TCI) devices.
sevofluraneDrug
Also called Group SEVO
inhalator sevoflurane using sevoflurane vaporizer sevoflurane vaporizer.
| Study group | Role | What they receive |
|---|---|---|
| Group PRO | Active comparator | Anesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg.
Anesthesia was maintained with propofol in TCI effect compartment concentration 3-4ug/kg. Receives: Drug: Propofol |
| Group SEVO | Active comparator | Anesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane in the method of vital capacity with inspired-limb drug concentration measured upon 6%.
Anesthesia was then maintained with sevoflurane in vaporizer concentration 1.5-2%. Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-40 scales 24 hours after surgery
We evaluate the quality of recovery with QoR-40 questionnaire 24 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain.
Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
Measured: 24 hours after surgery
QoR-40 scales 48 hours after surgery
We evaluate the quality of recovery with QoR-40 questionnaire 48 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain.
Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
Measured: 48 hours after surgery
Secondary outcomes (6)
Duration of induction
From beginning of intravenous or inhalation of anesthetics to ending of inserting the LMA.
Measured: Procedure (After inserting the laryngeal mask airway(LMA ))
Duration of surgery
From beginning of skin cutting to ending of surgery.
Measured: Intraoperative
Duration of emergence
From withdrawl time of intravenous or inhalation of anesthetics to awaking.
Measured: procedure (After emergence from anesthesia)
visual analogue scales for pain
visual analogue scales for pain in PACU
Measured: 1 day (at the time of leaving PACU)
PONV
Postoperative nausea and vomiting in 24hours after surgery
Measured: 24 hours after surgery
total dosage of Analgesic drugs
Categories of analgesics and total dosage of analgesics in 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: In the early stage of the research, this research was limited by the application permission of research drugs and instruments, and the research will have to be interrupted, which is extremely regrettable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Quality of RecoveryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangang Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiangang Song, ShuGuang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529875
- Sponsor's protocol ID
- 20160401
- Status last verified
- Sep 2022
- First submitted
- 7 May 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montgomery JS, Gayed BA, Hollenbeck BK, Daignault S, Sanda MG, Montie JE, Wei JT. Obesity adversely affects health related quality of life before and after radical retropubic prostatectomy. J Urol. 2006 Jul;176(1):257-61; discussion 261-2. doi: 10.1016/S0022-5347(06)00504-0.
PubMed 16753415Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009.
PubMed 15809132Nakazawa K, Hikawa Y, Maeda M, Tanaka N, Ishikawa S, Makita K, Amaha K. Laryngeal mask airway insertion using propofol without muscle relaxants: a comparative study of pretreatment with midazolam or fentanyl. Eur J Anaesthesiol. 1999 Aug;16(8):550-5. doi: 10.1046/j.1365-2346.1999.00540.x.
PubMed 10500946Philip BK, Lombard LL, Roaf ER, Drager LR, Calalang I, Philip JH. Comparison of vital capacity induction with sevoflurane to intravenous induction with propofol for adult ambulatory anesthesia. Anesth Analg. 1999 Sep;89(3):623-7. doi: 10.1097/00000539-199909000-00014.
PubMed 10475291Leger M, Campfort M, Cayla C, Lasocki S, Rineau E. Postoperative quality of recovery measurements as endpoints in comparative anaesthesia studies: a systematic review. Br J Anaesth. 2021 Jun;126(6):e210-e212. doi: 10.1016/j.bja.2021.03.008. Epub 2021 Apr 21. No abstract available.
PubMed 33892949Niu Z, Gao X, Shi Z, Liu T, Wang M, Guo L, Qi D. Effect of total intravenous anesthesia or inhalation anesthesia on postoperative quality of recovery in patients undergoing total laparoscopic hysterectomy: A randomized controlled trial. J Clin Anesth. 2021 Oct;73:110374. doi: 10.1016/j.jclinane.2021.110374. Epub 2021 Jun 2.
PubMed 34090183Shen Y, Liu Y, Wu Y, He J. Changes of recovery quality and early cognitive function after treatment of sevoflurane combined with propofol in the elderly undergoing cholecystectomy. Am J Transl Res. 2021 Oct 15;13(10):11868-11874. eCollection 2021.
PubMed 34786116Senoner T, Velik-Salchner C, Luckner G, Tauber H. Anesthesia-Induced Oxidative Stress: Are There Differences between Intravenous and Inhaled Anesthetics? Oxid Med Cell Longev. 2021 Nov 27;2021:8782387. doi: 10.1155/2021/8782387. eCollection 2021.
PubMed 34873432Goertz L, Stavrinou P, Hamisch C, Perrech M, Czybulka DM, Mehdiani K, Timmer M, Goldbrunner R, Krischek B. Impact of Obesity on Complication Rates, Clinical Outcomes, and Quality of Life after Minimally Invasive Transforaminal Lumbar Interbody Fusion. J Neurol Surg A Cent Eur Neurosurg. 2021 Mar;82(2):147-153. doi: 10.1055/s-0040-1718758. Epub 2020 Dec 22.
PubMed 33352610Xu S, Chen JY, Lo NN, Chia SL, Tay DKJ, Pang HN, Hao Y, Yeo SJ. The influence of obesity on functional outcome and quality of life after total knee arthroplasty: a ten-year follow-up study. Bone Joint J. 2018 May 1;100-B(5):579-583. doi: 10.1302/0301-620X.100B5.BJJ-2017-1263.R1.
PubMed 29701098Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) investigators. Propofol compared with sevoflurane general anaesthesia is associated with decreased delayed neurocognitive recovery in older adults. Br J Anaesth. 2018 Sep;121(3):595-604. doi: 10.1016/j.bja.2018.05.059. Epub 2018 Jul 27.
PubMed 30115258Siampalioti A, Karavias D, Zotou A, Kalfarentzos F, Filos K. Anesthesia management for the super obese: is sevoflurane superior to propofol as a sole anesthetic agent? A double-blind randomized controlled trial. Eur Rev Med Pharmacol Sci. 2015 Jul;19(13):2493-500.
PubMed 26214787Schwandner O. Obesity is a negative predictor of success after surgery for complex anal fistula. BMC Gastroenterol. 2011 May 23;11:61. doi: 10.1186/1471-230X-11-61.
PubMed 21605391Cortinez LI, Gambus P, Troconiz IF, Echevarria G, Munoz HR. Obesity does not influence the onset and offset of sevoflurane effect as measured by the hysteresis between sevoflurane concentration and bispectral index. Anesth Analg. 2011 Jul;113(1):70-6. doi: 10.1213/ANE.0b013e31821f105c. Epub 2011 May 19.
PubMed 21596877Peduto VA, Mezzetti D, Properzi M, Giorgini C. Sevoflurane provides better recovery than propofol plus fentanyl in anaesthesia for day-care surgery. Eur J Anaesthesiol. 2000 Feb;17(2):138-43. doi: 10.1046/j.1365-2346.2000.00626.x.
PubMed 10758459
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery for Anal Fistula in Obese Patients: A Prospective, Randomized, Single-blinded, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05529875
- Acronym / sponsor ID
- 20160401
- Conditions
- Quality of Recovery
- Keywords
- propofol, sevoflurane, obese, quality of recovery, anal fistula
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In the early stage of the research, this research was limited by the application permission of research drugs and instruments, and the research will have to be interrupted, which is extremely regrettable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangang SongUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 7 Sep 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.
This study was designed to compare propofol intravenous anesthesia to sevoflurane inhalation anesthesia on the quality of recovery after surgery for anal fistula in obese patients. Propofol-based total intravenous anesthesia (TIVA) and sevoflurane inhalation anesthesia are the two main anesthesia techniques. Obesity influences not only anesthetics metabolic but also physical function of patients, so it is meaningful to study which anesthesia technique is better for the recovery of obese patients after surgery.
Detailed description
This study was approved by Ethical Committee of ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese Medicine. Patients were given informed consent before enrolling the study, whereafter, they were randomized into two groups, propofol-based total intravenous anesthesia (Group PRO) and sevoflurane inhalation anesthesia (Group SEVO). After entering the routine, blood pressure, pulse oxygen saturation, and ECG were monitored by multifunctional anesthesia monitor and anesthesia depth was monitored by brain electrical bispectral index (BIS). Intravenous access (20-gauge catheter) was established and an infusion of lactated Ringer's solution began in the operating room. Patients were positioned as left or right lateral decubitus position according to surgery. Patients inhaled oxygen before anesthetic induction using a face mask. Intravenous penehyclidine hydrochloride 0.5mg, granisetron 3mg, and midazolam 2mg were given as premedication.
In Group PRO, anesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg, until the patient loses consciousness, then laryngeal mask airway was inserted. Anesthesia was then maintained with propofol in TCI 3-4ug/kg, if the patient showed body movement, TCI was raised by 0.5 ug/kg every time, until the anesthesia depth was satisfied (no body movement, BIS40-60).
In Group SEVO, anesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane. Firstly, mask was fixed with four head band, keeping it sealed. The method of vital capacity was used, taking deep breaths until the patient loses consciousness (call patients not to answer, the eyelash reflex disappeared, BIS40-60): close valve of APL to zero, empty the breathing bag, block the respiratory circuit, prime the circuit with 8% sevoflurane in O2 at 8 L/min until the inspired-limb drug concentration measured upon 6%. Then, laryngeal mask airway was inserted. Anesthesia was then maintained with sevoflurane, adjusting the oxygen flow rate to 2L/min and sevoflurane vaporizer concentration 1.5-2%, if the patient showed body movement and other narcotic lighter sign, sevoflurane vaporizer concentration was raised by 0.5% every time, until the anesthesia depth was satisfied (no body movement, BIS40-60).
The propofol and sevoflurane were closed at the end of surgery.
Quality of recovery was assessed using QoR-40 scale in day 1 and day 2 after surgery. Postoperative pain intensity was assessed using visual analogue scale in day 1 and day 2 after surgery. Surgical and waking time was recorded before leaving post-anesthesia care unit. Adverse events (circulation or respiratory depression, postoperative nausea and vomiting, recovery agitation) were recorded perioperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PRO | Active comparator | Drug: PropofolAnesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg. Anesthesia was maintained with propofol in TCI effect compartment concentration 3-4ug/kg. |
| Group SEVO | Active comparator | Drug: sevofluraneAnesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane in the method of vital capacity with inspired-limb drug concentration measured upon 6%. Anesthesia was then maintained with sevoflurane in vaporizer concentration 1.5-2%. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients undergoing selective surgery for anal fistula,
- aged 18-60 years,
- body mass index >30kg/m2,
- patient who required general anesthesia and signed informed consent,
- ASA I - II.
Key exclusion criteria (9 listed)
- patients refused to participate in the test,
- patients with severe cardiac, pulmonary, liver and renal dysfunction,
- patients with severe central nervous system diseases or severe mental diseases,
- patients with a history of alcoholism,
- allergy to related anesthetics,
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 |
|---|---|---|
| PropofolAlso: Group PROintravenous propofol using target-controlled infusion (TCI) devices. | Drug | Group PRO |
| sevofluraneAlso: Group SEVOinhalator sevoflurane using sevoflurane vaporizer sevoflurane vaporizer. | Drug | Group SEVO |
Primary outcome
QoR-40 scales 24 hours after surgery
Time frame: 24 hours after surgery
We evaluate the quality of recovery with QoR-40 questionnaire 24 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain. Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
QoR-40 scales 48 hours after surgery
Time frame: 48 hours after surgery
We evaluate the quality of recovery with QoR-40 questionnaire 48 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain. Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
6 secondary outcomes
Duration of induction
Time frame: Procedure (After inserting the laryngeal mask airway(LMA ))
Duration of surgery
Time frame: Intraoperative
Duration of emergence
Time frame: procedure (After emergence from anesthesia)
visual analogue scales for pain
Time frame: 1 day (at the time of leaving PACU)
PONV
Time frame: 24 hours after surgery
total dosage of Analgesic drugs
Time frame: 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 16753415Montgomery JS, Gayed BA, Hollenbeck BK, Daignault S, Sanda MG, Montie JE, Wei JT. Obesity adversely affects health related quality of life before and after radical retropubic prostatectomy. J Urol. 2006 Jul;176(1):257-61; discussion 261-2. doi: 10.1016/S0022-5347(06)00504-0.
- Background: PubMed 15809132Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009.
- Background: PubMed 10500946Nakazawa K, Hikawa Y, Maeda M, Tanaka N, Ishikawa S, Makita K, Amaha K. Laryngeal mask airway insertion using propofol without muscle relaxants: a comparative study of pretreatment with midazolam or fentanyl. Eur J Anaesthesiol. 1999 Aug;16(8):550-5. doi: 10.1046/j.1365-2346.1999.00540.x.
- Background: PubMed 10475291Philip BK, Lombard LL, Roaf ER, Drager LR, Calalang I, Philip JH. Comparison of vital capacity induction with sevoflurane to intravenous induction with propofol for adult ambulatory anesthesia. Anesth Analg. 1999 Sep;89(3):623-7. doi: 10.1097/00000539-199909000-00014.
- Results publication: PubMed 33892949Leger M, Campfort M, Cayla C, Lasocki S, Rineau E. Postoperative quality of recovery measurements as endpoints in comparative anaesthesia studies: a systematic review. Br J Anaesth. 2021 Jun;126(6):e210-e212. doi: 10.1016/j.bja.2021.03.008. Epub 2021 Apr 21. No abstract available.
- Results publication: PubMed 34090183Niu Z, Gao X, Shi Z, Liu T, Wang M, Guo L, Qi D. Effect of total intravenous anesthesia or inhalation anesthesia on postoperative quality of recovery in patients undergoing total laparoscopic hysterectomy: A randomized controlled trial. J Clin Anesth. 2021 Oct;73:110374. doi: 10.1016/j.jclinane.2021.110374. Epub 2021 Jun 2.
- Results publication: PubMed 34786116Shen Y, Liu Y, Wu Y, He J. Changes of recovery quality and early cognitive function after treatment of sevoflurane combined with propofol in the elderly undergoing cholecystectomy. Am J Transl Res. 2021 Oct 15;13(10):11868-11874. eCollection 2021.
- Results publication: PubMed 34873432Senoner T, Velik-Salchner C, Luckner G, Tauber H. Anesthesia-Induced Oxidative Stress: Are There Differences between Intravenous and Inhaled Anesthetics? Oxid Med Cell Longev. 2021 Nov 27;2021:8782387. doi: 10.1155/2021/8782387. eCollection 2021.
- Results publication: PubMed 33352610Goertz L, Stavrinou P, Hamisch C, Perrech M, Czybulka DM, Mehdiani K, Timmer M, Goldbrunner R, Krischek B. Impact of Obesity on Complication Rates, Clinical Outcomes, and Quality of Life after Minimally Invasive Transforaminal Lumbar Interbody Fusion. J Neurol Surg A Cent Eur Neurosurg. 2021 Mar;82(2):147-153. doi: 10.1055/s-0040-1718758. Epub 2020 Dec 22.
- Results publication: PubMed 29701098Xu S, Chen JY, Lo NN, Chia SL, Tay DKJ, Pang HN, Hao Y, Yeo SJ. The influence of obesity on functional outcome and quality of life after total knee arthroplasty: a ten-year follow-up study. Bone Joint J. 2018 May 1;100-B(5):579-583. doi: 10.1302/0301-620X.100B5.BJJ-2017-1263.R1.
- Results publication: PubMed 30115258Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) investigators. Propofol compared with sevoflurane general anaesthesia is associated with decreased delayed neurocognitive recovery in older adults. Br J Anaesth. 2018 Sep;121(3):595-604. doi: 10.1016/j.bja.2018.05.059. Epub 2018 Jul 27.
- Results publication: PubMed 26214787Siampalioti A, Karavias D, Zotou A, Kalfarentzos F, Filos K. Anesthesia management for the super obese: is sevoflurane superior to propofol as a sole anesthetic agent? A double-blind randomized controlled trial. Eur Rev Med Pharmacol Sci. 2015 Jul;19(13):2493-500.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and sevoflurane in people with Quality of Recovery, run by Jiangang Song 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 7 Sep 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
QoR-40 scales 24 hours after surgery (time frame: 24 hours after surgery). The study lists 2 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 NCT05529875, which also lists 15 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 7 Sep 2022.