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临床试验/NCT05529875
NCT05529875撤回不适用

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

Jiangang Song1 个研究点 分布在 1 个国家开始时间: 2022年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
QoR-40 scales 48 hours after surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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,
  • 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, ____________________________________________.

研究组 & 干预措施

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.

干预措施: Propofol (Drug)

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%.

干预措施: sevoflurane (Drug)

结局指标

主要结局

QoR-40 scales 48 hours after surgery

时间窗: 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.

QoR-40 scales 24 hours after surgery

时间窗: 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.

次要结局

  • Duration of surgery(Intraoperative)
  • Duration of induction(Procedure (After inserting the laryngeal mask airway(LMA )))
  • total dosage of Analgesic drugs(24 hours after surgery)
  • Duration of emergence(procedure (After emergence from anesthesia))
  • visual analogue scales for pain(1 day (at the time of leaving PACU))
  • PONV(24 hours after surgery)

研究者

发起方
Jiangang Song
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jiangang Song

Head of Anesthesiology

ShuGuang Hospital

研究点 (1)

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