Laparoscopic SurgeryPhase 4NCT01084200
Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia
A Phase 4 study testing Propofol for maintenance, Sevoflurane and Sevoflurane+Propofol in people with Laparoscopic Surgery and Hysteroscopic Surgery, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Laparoscopic Surgery, Hysteroscopic Surgery
- What is being tested?
- Propofol for maintenance, Sevoflurane and Sevoflurane+Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status class 1 or 2
- Aged >=18 years and =<40 years old
- Suffering from infertilities
- Under elective gynaecological laparoscopic and hysteroscopic surgery
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery
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.
Read the 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.
- Conditions
- Laparoscopic Surgery, Hysteroscopic Surgery
- Being tested
- Propofol for maintenance, Sevoflurane, Sevoflurane+Propofol
- Keywords
- Postoperative pain, Sevoflurane, Propofol, Female, Elective gynaecological surgery, Laparoscopic and hysteroscopic surgery, Female patients, Undergoing elective laparoscopic and hysteroscopic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol for maintenanceDrug
Also called Propofol
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
Also called Sevoflurane and Propofol
Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | anesthesia maintenance with propofol and remifentanil Receives: Drug: Propofol for maintenance |
| Sevoflurane | Experimental | Sevoflurane and Remifentanil for anesthesia maintenance Receives: Drug: Sevoflurane |
| Sevoflurane+Propofol | Experimental | Sevoflurane+Propofol for anesthesia maintenance Receives: Drug: Sevoflurane+Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 0.5h after the surgery
Secondary outcomes (5)
Postoperative delirium
Postoperative delirium determined by Nu-DESC every 8 hours.
Measured: 24 hours postoperatively
PONV
Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery.
Measured: 24 hours postoperatively
QOR
Quality of recovery was determined by QOR40 at 24h after the surgery
Measured: 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.
Measured: at 1h and 24h after surgery
Incidence of shivering in the first postoperative day.
Incidence of shivering was assessed at 24h after the surgery.
Measured: follow up at 24 h after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, M.D., Principal investigator, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyYu Ke Tian, Prof. M.D., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084200
- Sponsor's protocol ID
- TJHMZK01004
- Status last verified
- Aug 2012
- First submitted
- 8 Mar 2010
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li M, Mei W, Wang P, Yu Y, Qian W, Zhang ZG, Tian YK. Propofol reduces early post-operative pain after gynecological laparoscopy. Acta Anaesthesiol Scand. 2012 Mar;56(3):368-75. doi: 10.1111/j.1399-6576.2011.02603.x. Epub 2011 Dec 23.
PubMed 22192060
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01084200
- Acronym / sponsor ID
- TJHMZK01004
- Conditions
- Laparoscopic Surgery, Hysteroscopic Surgery
- Keywords
- Postoperative pain, Sevoflurane, Propofol, Female, Elective gynaecological surgery, Laparoscopic and hysteroscopic surgery, Female patients, Undergoing elective laparoscopic and hysteroscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Propofol for maintenanceanesthesia maintenance with propofol and remifentanil |
| Sevoflurane | Experimental | Drug: SevofluraneSevoflurane and Remifentanil for anesthesia maintenance |
| Sevoflurane+Propofol | Experimental | Drug: Sevoflurane+PropofolSevoflurane+Propofol for anesthesia maintenance |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status class 1 or 2
- Aged >=18 years and =<40 years old
- Suffering from infertilities
- Under elective gynaecological laparoscopic and hysteroscopic surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol for maintenanceAlso: PropofolPropofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance | Drug | Propofol |
| SevofluraneSevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance | Drug | Sevoflurane |
| Sevoflurane+PropofolAlso: Sevoflurane and PropofolSevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance | Drug | Sevoflurane+Propofol |
Primary outcome
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.
5 secondary outcomes
Postoperative delirium
Time frame: 24 hours postoperatively
PONV
Time frame: 24 hours postoperatively
QOR
Time frame: 24 hours post operatively
Post operative pain determined by NRS at 1h and 24h after surgery
Time frame: at 1h and 24h after surgery
Incidence of shivering in the first postoperative day.
Time frame: follow up at 24 h after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
- Results publication: PubMed 22192060Li M, Mei W, Wang P, Yu Y, Qian W, Zhang ZG, Tian YK. Propofol reduces early post-operative pain after gynecological laparoscopy. Acta Anaesthesiol Scand. 2012 Mar;56(3):368-75. doi: 10.1111/j.1399-6576.2011.02603.x. Epub 2011 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Mei, M.D. principal investigator
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Yu Ke Tian, Prof. M.D. study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol for maintenance, Sevoflurane and Sevoflurane+Propofol in people with Laparoscopic Surgery and Hysteroscopic Surgery, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain determined by NRS at 0.5h after surgery (time frame: at 0.5h after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.