Comparison between two groups of drugs for prevention of nausea & vomiting in women after surgery on uterus or ovaries.
Phase 3
- Conditions
- Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system
- Registration Number
- CTRI/2023/08/056860
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ASA physical status I/II
Scheduled for laparoscopic procedures >1hr duration
Exclusion Criteria
1. History of hypersensitivity or allergic reaction to ondansetron or haloperidol
2. Established diagnosis or family history of congenital long QT syndrome
3. Parkinsons disease
4. Use of anti emetic within 24 hours of surgery
5. Use of antipsychotic drugs
6. Pregnant patients
7. Obese patients (BMI >30)
8. Electrolyte abnormalities
9. Haemodynamic instability in the peri operative period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of nausea using 11 point verbal numerical rating scale & number of episodes of vomiting <br/ ><br>Timepoint: First 24 hours following laparoscopic gynaecological procedure
- Secondary Outcome Measures
Name Time Method corrected QT intervalTimepoint: within first hour following laparoscopic gynaecological procedure;Extent of sedationTimepoint: First 24 hours following laparoscopic gynaecological procedure, using Observers assessment of alertness/sedation scale;Incidence of delirium using confusion assessment method (CAM)Timepoint: First 24 hours following laparoscopic gynaecological procedure;Post operative analgesiaTimepoint: First 24 hours following laparoscopic gynaecological procedure, using Visual Analog Score (VAS);Requirement of rescue antiemeticTimepoint: First 24 hours following laparoscopic gynaecological procedure, & name of drug administered;Time to administration of rescue antiemeticTimepoint: from end of procedure to occurrence of first episode of vomiting or sensation of nausea