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Completed

NCT Number: NCT01084200

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol for maintenance

Drug

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

Other names: Propofol

Sevoflurane

Drug

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

Sevoflurane+Propofol

Drug

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

Other names: Sevoflurane and Propofol

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative delirium

    Time frame: 24 hours postoperatively

    Postoperative delirium determined by Nu-DESC every 8 hours.

  2. PONV

    Time frame: 24 hours postoperatively

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

  3. QOR

    Time frame: 24 hours post operatively

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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 10, 2010
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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