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To see effect on Nausea and vomiting after brain tumour surgery if Tablet Amisulpride is given orally in single dose.

TO EVALUATE THE ROLE OF SINGLE PREOPERATIVE ORAL AMISULPRIDE ON POSTOPERATIVE NAUSEA AND VOMITING IN PATIENT UNDERGOING CRANIOTOTOMY

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027791
Enrollment
100
Registered
2020-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Drug Oral AMisulpride: Intervention group: Oral Amisulpride 25 mg Control: Placebo (Drug/Placebo to be given 2 hours before surgery)

Sponsors

Department of Anesthesiology SGPGIMS Lucknow
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patient belonging to ASA I-II, 18 year to 60 years of either sex scheduled for craniotomy for supra- tentorial tumors requiring undergoing general anaesthesia will be included in the study.

Exclusion criteria

Exclusion criteria: Patients with history of nausea or vomiting 24 hours before surgery, drug or alcohol abusers, pregnant or lactating women, recipients of chemotherapy or radiation therapy during the previous 7 days, renal insufficiency, mental disorder or unconscious before the surgery who cannot normally communicate, menstruating phase of the menstrual cycle, history of epilepsy and still taking an anti-epileptic medicine, undergoing ventricle or brainstem surgery will be excluded.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be incidence of nausea and/or vomiting or retching.Timepoint: 24 hour postoperative

Secondary

MeasureTime frame
Secondary outcome will be severity of nausea, number of times rescue medication used, postoperative pain, postoperative analgesia and incidences of other critical incidences within 24 hours postoperatively. Timepoint: Five interval. 1, 2, 4, 8, and 24 hours

Countries

India

Contacts

Public ContactANUBHA GUPTA

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

drdevendragpt@yahoo.com09919754895

Outcome results

None listed

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