Hysteroscopic Surgery, Laparoscopic Surgery
Conditions
Keywords
Postoperative pain, Sevoflurane, Propofol, Female, Elective gynaecological surgery, Laparoscopic and hysteroscopic surgery, Female patients, Undergoing elective laparoscopic and hysteroscopic surgery
Brief summary
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
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.
Interventions
DRUGPropofol for maintenance
Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
DRUGSevoflurane
Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
DRUGSevoflurane+Propofol
Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain determined by NRS at 0.5h after surgery | at 0.5h after the surgery | The level of postoperative pain was assessed by Numerical Analogue Scale (NAS) at rest at 0.5 hour after the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | 24 hours postoperatively | Postoperative delirium determined by Nu-DESC every 8 hours. |
| PONV | 24 hours postoperatively | Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery. |
| QOR | 24 hours post operatively | Quality of recovery was determined by QOR40 at 24h after the surgery |
| Post operative pain determined by NRS at 1h and 24h after surgery | at 1h and 24h after surgery | Post operative pain determined by NRS at 1h and 24h after surgery respectively. |
| Incidence of shivering in the first postoperative day. | follow up at 24 h after the surgery | Incidence of shivering was assessed at 24h after the surgery. |
Countries
China
Outcome results
None listed