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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery

Conditions
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Laparoscopic Surgery, Hysteroscopic Surgery

Intervention / Treatment
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* Drug: Propofol for maintenance
* Drug: Sevoflurane
* Drug: Sevoflurane+Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>anesthesia maintenance with propofol and remifentanil | Drug: Propofol for maintenance<br>* Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance<br>* Other names: Propofol;|
| Experimental: Sevoflurane<br>Sevoflurane and Remifentanil for anesthesia maintenance | Drug: Sevoflurane<br>* Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance<br>|
| Experimental: Sevoflurane+Propofol<br>Sevoflurane+Propofol for anesthesia maintenance | Drug: Sevoflurane+Propofol<br>* Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance<br>* Other names: Sevoflurane and Propofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 0.5h after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium determined by Nu-DESC every 8 hours. | 24 hours postoperatively | 
| PONV | Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery. | 24 hours postoperatively | 
| QOR | Quality of recovery was determined by QOR40 at 24h after the surgery | 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. | at 1h and 24h after surgery | 
| Incidence of shivering in the first postoperative day. | Incidence of shivering was assessed at 24h after the surgery. | follow up at 24 h after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Sevoflurane, Propofol, Female, Elective gynaecological surgery, Laparoscopic and hysteroscopic surgery, Female patients, Undergoing elective laparoscopic and hysteroscopic surgery