Comparing drugs Amisulpride and Dexamethasone in reducing nausea and vomiting after surgery in high risk patients.

Comparing the efficacy of intravenous Amisulpride and Dexamethasone in preventing postoperative nausea and vomiting in high risk patients : A randomized controlled double blind study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097398

Enrollment

324

Registered

2025-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: inj. Amisulpride 5mg: inj Amisulpride 5mg will be given 10 min prior to induction of anaesthesia to group A and patient will be monitored for adverse effect like QT prolongation. Cont

Eligibility

Inclusion criteria

Inclusion criteria: 1) Apfel criteria of more than 2. 2) American society of anaesthesiologists (ASA) physical class I-II 3) Non-smoker

Exclusion criteria

Exclusion criteria: 1) Patient refusal to participate in study 2) Any previous history of drug reaction to amisulpride 3) Patient with severe hepatic or renal dysfunction or cardiac dysfunction 4) Patient requiring orogastric /nasogastric tube in the post-operative period. 5) Patient with poorly controlled diabetes mellitus – HbA1c more than 9 6) Patient on medications which prolong QT interval. 7) Patient on other antipsychotic medications.

Design outcomes

Primary

Measure	Time frame
Incidence of Postoperative Nausea and Vomiting (PONV) in 24 hrs of post operative period: In the ward, episodes of vomiting, retching will be recorded, and nausea score as per 11-point verbal rating scale from 0-10 with zero being no nausea and 10 being worst possible nausea and significant nausea defined as a score of 4 and above. Timepoint: Above findings will be evaluated at 1st, 2nd, 6th, 12th and 24 hours of post-operative period	—

Measure

Time frame

Incidence of Postoperative Nausea and Vomiting (PONV) in 24 hrs of post operative period: In the ward, episodes of vomiting, retching will be recorded, and nausea score as per 11-point verbal rating scale from 0-10 with zero being no nausea and 10 being worst possible nausea and significant nausea defined as a score of 4 and above. Timepoint: Above findings will be evaluated at 1st, 2nd, 6th, 12th and 24 hours of post-operative period

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Secondary

Measure	Time frame
1. Total dose of rescue anti emetic recorded in post operative period of 24 hours 2. Duration of PACU stay 3. Any amisulpride related adverse events in post operative period of 24 hours Timepoint: total dose of rescue antiemetic (injection ondansetron) at the end of 24 hrs post op period. Duration of pacu stay ( duration in post op till patient is shifted from pacu to ward) adverse events will be followed up for at 1st , 2nd , 6th & 24th hours of post operative period.	—

Measure

Time frame

1. Total dose of rescue anti emetic recorded in post operative period of 24 hours 2. Duration of PACU stay 3. Any amisulpride related adverse events in post operative period of 24 hours Timepoint: total dose of rescue antiemetic (injection ondansetron) at the end of 24 hrs post op period. Duration of pacu stay ( duration in post op till patient is shifted from pacu to ward) adverse events will be followed up for at 1st , 2nd , 6th & 24th hours of post operative period.

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Countries

India

Contacts

Public ContactDr Priyanka Gupta

All India Institute of Medical Sciences,Rishikesh

drpriyankagupta84@gmail.com9811894899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026