To Compare Safety And Efficacy Of Low Dose And High Dose Of Intravenous Amisulpride In Prevention Of Nausea And Vomiting In Middle Ear Surgeries
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Teerthanker Mahaveer Medical College and Research Centre
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To note occurrence of Intraoperative Nausea and Vomiting
Overview
Brief Summary
This study aims to compare the safety and efficacy of low-dose (5mg) and high-dose (10mg) intravenous amisulpride in preventing postoperative nausea and vomiting (PONV) in patients undergoing middle ear surgeries. These surgeries increase the risk of PONV due to vestibular stimulation from drilling and irrigation. Amisulpride, a D2-D3 antagonist, has shown effectiveness in preventing PONV, though the optimal dose remains unclear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient posted for Elective Middle Ear Surgeries Patient giving written and informed consent American Society of Anesthesiologist (ASA) grade I-II[7] Age group of 18-65 years old Apfel Score ≥ 2.
Exclusion Criteria
- •Patient on any Psychotropic drug smokers Pregnant Females.
Outcomes
Primary Outcomes
To note occurrence of Intraoperative Nausea and Vomiting
Time Frame: Baseline( At time of Extubation) | 15 mins | 30 mins | 45 mins | 1 hour | 2 hours | 3 hours | 4 hours | 8 hours | 12 hours | 24 hours
To compare severity of Nausea Vomiting for 24 hours
Time Frame: Baseline( At time of Extubation) | 15 mins | 30 mins | 45 mins | 1 hour | 2 hours | 3 hours | 4 hours | 8 hours | 12 hours | 24 hours
Secondary Outcomes
- To compare the time for onset of first episode of Nausea Vomiting(To compare the efficacy of intravenous amisulpride by noting the Verbal Rating Score (VRS))
Investigators
Dr Paigam Prinja
Teerthanker Mahaveer Medical College and Research Centre