Pain, PostoperativePhase 4NCT01304953
Tropisetron on Postoperative Pain
A Phase 4 study testing Group P+P, Group P+T and Group S+P in people with Pain, Postoperative, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several animal models. However, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Group P+P, Group P+T and Group S+P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients
- American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- undergoing selective gynaecological laparoscopies for infertilities
Who cannot join
- aged under 18 years old
- body mass index (BMI) > 30
- history of cardiovascular disease
- history of respiratory disease
- history of neurologic disease
- history of chronic antidepressants
Show all 9Show fewer
- history of anxiolytics
- history of chronic analgesics intake
- participating in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy
The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several animal models. However, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain than those anaesthetized with propofol. And we further posit that the difference is due to the nociceptive processing induced by the action of 5-HT3A receptors.
In this prospective, randomized, double-blind, placebo-controlled study, we assessed the analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.
- Conditions
- Pain, Postoperative
- Being tested
- Group P+P, Group P+T, Group S+P, Group S+T
- Keywords
- General anaesthetics, gynaecological laparoscopy, anaesthetic i.v., propofol, anaesthetic volatile, evoflurane, antiemetics, reopisetron, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group P+PDrug
In this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received saline placebo i.v. after the induction of anaesthesia.
Group P+TDrug
In this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia.
Group S+PDrug
In this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received saline placebo i.v. after the induction of anaesthesia.
Group S+TDrug
In this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| P+P | Placebo comparator | Not described Receives: Drug: Group P+P |
| P+T | Experimental | Not described Receives: Drug: Group P+T |
| S+P | Placebo comparator | Not described Receives: Drug: Group S+P |
| S+T | Experimental | Not described Receives: Drug: Group S+T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain at rest
The primary outcome was the postoperative pain at rest assessed by numeric analog score (NAS, where 0 indicates no pain, and 10 indicates the most severe pain) immediately after awaking.
Measured: At 0.5 postoperative hour
Secondary outcomes (5)
Postoperative pain at rest
The patients were instructed to give the number that represented the pain level at rest soon after awakening, the first 30 min postoperatively, and every 2 hours within the first 24 postoperative hours.
Measured: At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours
Intraoperative hemodynamic values
Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture
Measured: At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture
Postoperative shivering
The incidence of shiver within 24 h was recorded.
Measured: At 24 hour postoperativelly
The incidence of postoperative nausea and vomiting (PONV)
The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.
Measured: At 24 hour postoperativelly
Quality of Recovery Score 40
Quality of Recovery Score 40 was determined at 24 hours postoperativelly
Measured: At 24 postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Investigators
- Wei Mei, Study director, Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, ChinaYuke Tian, MD., Study chair, Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304953
- Sponsor's protocol ID
- TJHMZK11001
- Status last verified
- Feb 2011
- First submitted
- 25 Feb 2011
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy
- ClinicalTrials.gov ID
- NCT01304953
- Acronym / sponsor ID
- TJHMZK11001
- Conditions
- Pain, Postoperative
- Keywords
- General anaesthetics, gynaecological laparoscopy, anaesthetic i.v., propofol, anaesthetic volatile, evoflurane, antiemetics, reopisetron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Feb 2011 (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.
The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several animal models. However, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain than those anaesthetized with propofol. And we further posit that the difference is due to the nociceptive processing induced by the action of 5-HT3A receptors.
In this prospective, randomized, double-blind, placebo-controlled study, we assessed the analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P+P | Placebo comparator | Drug: Group P+P |
| P+T | Experimental | Drug: Group P+T |
| S+P | Placebo comparator | Drug: Group S+P |
| S+T | Experimental | Drug: Group S+T |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female patients
- American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- undergoing selective gynaecological laparoscopies for infertilities
Key exclusion criteria (9 listed)
- aged under 18 years old
- body mass index (BMI) > 30
- history of cardiovascular disease
- history of respiratory disease
- history of neurologic disease
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 |
|---|---|---|
| Group P+PIn this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia. Patients in this arms received saline placebo i.v. after the induction of anaesthesia. | Drug | P+P |
| Group P+TIn this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia. Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia. | Drug | P+T |
| Group S+PIn this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia. Patients in this arms received saline placebo i.v. after the induction of anaesthesia. | Drug | S+P |
| Group S+TIn this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia. Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia. | Drug | S+T |
Primary outcome
Postoperative pain at rest
Time frame: At 0.5 postoperative hour
The primary outcome was the postoperative pain at rest assessed by numeric analog score (NAS, where 0 indicates no pain, and 10 indicates the most severe pain) immediately after awaking.
5 secondary outcomes
Postoperative pain at rest
Time frame: At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours
Intraoperative hemodynamic values
Time frame: At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture
Postoperative shivering
Time frame: At 24 hour postoperativelly
The incidence of postoperative nausea and vomiting (PONV)
Time frame: At 24 hour postoperativelly
Quality of Recovery Score 40
Time frame: At 24 postoperative hour
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 28 Feb 2011.
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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 study director
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Yuke Tian, MD. study chair
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
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 Group P+P, Group P+T and Group S+P in people with Pain, Postoperative, 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 3 inclusion and 9 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 28 Feb 2011. 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. Some participants in this study may receive a placebo. 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?
Postoperative pain at rest (time frame: At 0.5 postoperative hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2011.