Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia
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|ClinicalTrials.gov Identifier: NCT01084200|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : August 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Laparoscopic Surgery Hysteroscopic Surgery||Drug: Propofol for maintenance Drug: Sevoflurane Drug: Sevoflurane+Propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
anesthesia maintenance with propofol and remifentanil
Drug: Propofol for maintenance
Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
Other Name: Propofol
Sevoflurane and Remifentanil for anesthesia maintenance
Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
Sevoflurane+Propofol for anesthesia maintenance
Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
Other Name: Sevoflurane and Propofol
- Post operative pain determined by NRS at 0.5h after surgery [ Time Frame: 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.
- Postoperative delirium [ Time Frame: 24 hours postoperatively ]Postoperative delirium determined by Nu-DESC every 8 hours.
- PONV [ Time Frame: 24 hours postoperatively ]Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery.
- QOR [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: follow up at 24 h after the surgery ]Incidence of shivering was assessed at 24h after the surgery.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084200
|Tongji Hospital, Huazhong University of Science and Technology|
|Wuhan, Hubei, China, 430030|
|Principal Investigator:||Wei Mei, M.D.||Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology|
|Study Chair:||Yu Ke Tian, Prof. M.D.||Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology|