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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05529875
Enrollment
0
Registered
2022-09-07
Start date
2022-10-31
Completion date
2024-03-31
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Recovery

Keywords

propofol, sevoflurane, obese, quality of recovery, anal fistula

Brief 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.

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.

Interventions

DRUGPropofol

intravenous propofol using target-controlled infusion (TCI) devices.

DRUGsevoflurane

inhalator sevoflurane using sevoflurane vaporizer sevoflurane vaporizer.

Sponsors

Jiangang Song
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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, \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_.

Design outcomes

Primary

MeasureTime frameDescription
QoR-40 scales 24 hours after surgery24 hours after surgeryWe 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 surgery48 hours after surgeryWe 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.

Secondary

MeasureTime frameDescription
Duration of emergenceprocedure (After emergence from anesthesia)From withdrawl time of intravenous or inhalation of anesthetics to awaking.
visual analogue scales for pain1 day (at the time of leaving PACU)visual analogue scales for pain in PACU
Duration of inductionProcedure (After inserting the laryngeal mask airway(LMA ))From beginning of intravenous or inhalation of anesthetics to ending of inserting the LMA.
total dosage of Analgesic drugs24 hours after surgeryCategories of analgesics and total dosage of analgesics in 24 hours after surgery
PONV24 hours after surgeryPostoperative nausea and vomiting in 24hours after surgery
Duration of surgeryIntraoperativeFrom beginning of skin cutting to ending of surgery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026