Tropisetron on Postoperative Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain, Postoperative |
Drug: Group P+P Drug: Group P+T Drug: Group S+P Drug: Group S+T |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy |
- Postoperative pain at rest [ Time Frame: At 0.5 postoperative hour ] [ Designated as safety issue: Yes ]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.
- Postoperative pain at rest [ Time Frame: At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours ] [ Designated as safety issue: Yes ]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.
- 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 ] [ Designated as safety issue: Yes ]Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture
- Postoperative shivering [ Time Frame: At 24 hour postoperativelly ] [ Designated as safety issue: Yes ]The incidence of shiver within 24 h was recorded.
- The incidence of postoperative nausea and vomiting (PONV) [ Time Frame: At 24 hour postoperativelly ] [ Designated as safety issue: Yes ]The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.
- Quality of Recovery Score 40 [ Time Frame: At 24 postoperative hour ] [ Designated as safety issue: Yes ]Quality of Recovery Score 40 was determined at 24 hours postoperativelly
| Enrollment: | 296 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: P+P |
Drug: Group P+P
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. |
| Experimental: P+T |
Drug: Group P+T
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. |
| Placebo Comparator: S+P |
Drug: Group S+P
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. |
| Experimental: S+T |
Drug: Group S+T
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. |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- female patients
- American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- undergoing selective gynaecological laparoscopies for infertilities
Exclusion Criteria:
- 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
- history of anxiolytics
- history of chronic analgesics intake
- participating in other studies
Contacts and Locations| China, Hubei | |
| Tongji Hospital | |
| Wuhan, Hubei, China, 430030 | |
| Study Director: | Wei Mei | Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China |
| Study Chair: | Yuke Tian, MD. | Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China |
More Information
No publications provided
| Responsible Party: | Prof. Yuke Tian, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology |
| ClinicalTrials.gov Identifier: | NCT01304953 History of Changes |
| Other Study ID Numbers: | TJHMZK11001 |
| Study First Received: | February 25, 2011 |
| Last Updated: | February 25, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Huazhong University of Science and Technology:
|
General anaesthetics gynaecological laparoscopy anaesthetic i.v. propofol anaesthetic volatile |
evoflurane antiemetics reopisetron postoperative pain |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Anesthetics Tropisetron Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013