Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery in Obese Patients

Quality of Recovery Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05529875
• Other study ID #: 20160401
• Status: Withdrawn
• Phase: N/A
• Start date: October 2022
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: ShuGuang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing selective surgery for anal fistula,

2. aged 18-60 years,

3. body mass index >30kg/m2,

4. patient who required general anesthesia and signed informed consent,

5. ASA I - II.

Exclusion Criteria:

1. patients refused to participate in the test,

2. patients with severe cardiac, pulmonary, liver and renal dysfunction,

3. patients with severe central nervous system diseases or severe mental diseases,

4. patients with a history of alcoholism,

5. allergy to related anesthetics,

6. pregnant or lactating women,

7. participated in the other trials in the past month,

8. taking any sedative, opioid, or sleep aid drugs,

9. patients with other special conditions not suitable for this study, ____________________________________________.

Related Conditions & MeSH terms

• Quality of Recovery
• Rectal Fistula

Intervention

Drug:
• Propofol
intravenous propofol using target-controlled infusion (TCI) devices.
• sevoflurane
inhalator sevoflurane using sevoflurane vaporizer sevoflurane vaporizer.

Locations

Country	Name	City	State
China	Shuguang Hospital of Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangang Song

Country where clinical trial is conducted

China, 

References & Publications (15)

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Cortínez LI, Gambús P, Trocóniz IF, Echevarría G, Muñoz 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 — View Citation

Goertz 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 N — View Citation

Léger 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 — View Citation

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. — View Citation

Nakazawa 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. — View Citation

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Peduto 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. — View Citation

Philip 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. — View Citation

Schwandner 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. — View Citation

Senoner 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. Review. — View Citation

Shen 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. — View Citation

Siampalioti 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): — View Citation

Xu 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 — View Citation

Zhang 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 o — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours after surgery
Primary	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.	48 hours after surgery
Secondary	Duration of induction	From beginning of intravenous or inhalation of anesthetics to ending of inserting the LMA.	Procedure (After inserting the laryngeal mask airway(LMA ))
Secondary	Duration of surgery	From beginning of skin cutting to ending of surgery.	Intraoperative
Secondary	Duration of emergence	From withdrawl time of intravenous or inhalation of anesthetics to awaking.	procedure (After emergence from anesthesia)
Secondary	visual analogue scales for pain	visual analogue scales for pain in PACU	1 day (at the time of leaving PACU)
Secondary	PONV	Postoperative nausea and vomiting in 24hours after surgery	24 hours after surgery
Secondary	total dosage of Analgesic drugs	Categories of analgesics and total dosage of analgesics in 24 hours after surgery	24 hours after surgery