Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia

Huazhong University of Science and Technology90 enrolled

Overview

Postoperative pain may be affected by general anaesthetics. The effect of propofol and sevoflurane on postoperative pain in chinese female patients has not been demonstrated before. This study compared the postoperative pain score in patients under general anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.

After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of female patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I or II, suffering from infertilities, and undergoing selective gynaecological laparoscopic and hysteroscopic surgery. All the patients were randomly assigned to receive propofol,sevoflurane,or sevoflurane+propofol for anaesthesia maintenance. The primary outcome measure was the level of postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 0.5 hour after the operation. The secondary outcomes were postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 1 and 24 hour after the operation, the incidence of postoperative nausea and vomiting, the incidence of shiver, and quality of recovery determined by QOR40 in the first 24 h after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Laparoscopic Surgery Hysteroscopic Surgery

Interventions

Propofol for maintenanceDRUG

Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance

SevofluraneDRUG

Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance

Sevoflurane+PropofolDRUG

Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA physical status class 1 or 2 * Aged \>=18 years and =\<40 years old * Suffering from infertilities * Under elective gynaecological laparoscopic and hysteroscopic surgery Exclusion Criteria: * ASA-PS\>=III * Aged under 18 yrs or above 40 yrs old * Body mass index (BMI) \>30 * Respiratory or Neurologic disease * Chronic antidepressants and Anticonvulsant drugs * Chronic analgesics intake * A known allergy to the drugs being used * History of substance abuse * Participating in the investigation of another experimental agent * Participating in the investigation of another study

Locations (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Post operative pain determined by NRS at 0.5h after surgery

The level of postoperative pain was assessed by Numerical Analogue Scale (NAS) at rest at 0.5 hour after the surgery.

Time frame: at 0.5h after the surgery

Secondary Outcomes

Postoperative delirium

Postoperative delirium determined by Nu-DESC every 8 hours.

Time frame: 24 hours postoperatively

PONV

Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery.

Time frame: 24 hours postoperatively

QOR

Quality of recovery was determined by QOR40 at 24h after the surgery

Time frame: 24 hours post operatively

Post operative pain determined by NRS at 1h and 24h after surgery

Post operative pain determined by NRS at 1h and 24h after surgery respectively.

Time frame: at 1h and 24h after surgery

Incidence of shivering in the first postoperative day.

Incidence of shivering was assessed at 24h after the surgery.

Time frame: follow up at 24 h after the surgery

Data from ClinicalTrials.gov

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