IV Amisulpride vs. Ondansetron to Prevent PONV in Patients Undergoing Neurosurgery
Introduction
Patients undergoing neurosurgical procedures are burdened with a high risk of post‑operative nausea and vomiting (PONV). Intravenous amisulpride, a dopamine (D2, D3) receptor antagonist, has been approved and has been found to be safe and effective in managing PONV in non‑neurosurgical settings. Nevertheless, the role of IV amisulpride has not been studied well in neurosurgical patients.
Aim
To compare the efficacy and safety of IV amisulpride (5 mg) vs. IV ondansetron (4 mg) in patients undergoing craniotomy for supratentorial tumour surgery
Patient profile
- Adult patients (age 18 to 65 years) scheduled for elective supratentorial craniotomy for tumour surgery under general anaesthesia.
Methods
Study Design
- A single‑centre, double‑blind, randomised study.
Treatment Strategy
- The study participants were randomised 1:1 to receive either IV amisulpride (5 mg) with IV paracetamol 1 gm or IV ondansetron (4 mg) with IV paracetamol 1 gm intra‑operatively, administered 30 minutes before skin closure.
Outcomes
Primary Outcome
- The incidence of PONV [defined as any episode of nausea (subjective unpleasant sensation associated with the urge to vomit) or vomiting] within the first 24 hours post‑operatively.
Secondary Outcomes
- Nausea severity (assessed using a 4-point numerical scale; 0 = no nausea, 4 = continuous vomiting)
- The need for rescue antiemetic medications
- The incidence of treatment‑related adverse events (AEs)
Results
- The final analysis included 100 patients.
- Patients treated with amisulpride had a significantly lower incidence of nausea and vomiting, as compared to those treated with ondansetron (Table 1).
- Patients treated with amisulpride, vs. those treated with ondansetron had a significantly lower severity of nausea during the first four post‑operative hours (Table 1).
- Furthermore, patients receiving amisulpride required fewer rescue antiemetics, as compared to those treated with ondansetron (Table 1).
Table 1: Outcomes in the study groups
|
Outcomes |
Amisulpride Group (N=50) |
Ondansetron Group (N=50) |
P value |
||
|
Incidence of Nausea |
22% |
36% |
0.032 |
||
|
Nausea severity scale |
|||||
|
Post-op time |
Number of patients (%) |
Severity |
Number of patients (%) |
Severity |
P value |
|
0‑1 h: n (%) |
4 (8%) |
Mild: 1 |
9 (18%) |
Mild: 4 |
0.046 |
|
Moderate: 1 |
Moderate: 3 |
||||
|
Severe: 2 |
Severe: 2 |
||||
|
1‑2 h: n (%) |
6 (12%) |
Mild: 3 |
12 (24%) |
Mild: 5 |
0.021 |
|
Moderate: 2 |
Moderate: 5 |
||||
|
Severe: 1 |
Severe: 2 |
||||
|
2‑4 h: n (%) |
2 (4%) |
Mild: 1 |
8 (16%) |
Mild: 4 |
0.011 |
|
Moderate: 1 |
Moderate: 3 |
||||
|
Severe: 0 |
Severe: 1 |
||||
|
4‑8 h: n (%) |
2 (2%) |
Mild: 2 |
4 (8%) |
Mild: 2 |
0.565 |
|
Moderate: 0 |
Moderate: 0 |
||||
|
Severe: 0 |
Severe: 2 |
||||
|
8‑24: h n (%) |
0 |
Mild: 0 |
0 |
Mild: 0 |
0.99 |
|
Moderate: 0 |
Moderate: 0 |
||||
|
Severe: 0 |
Severe: 0 |
||||
|
Incidence of vomiting: n (%) |
4 (8%) |
9 (18%) |
0.045 |
||
|
Episodes of vomiting (n)– 1/2/≥3 |
2/2/0 |
3/2/4 |
- |
||
|
Rescue medications n (%) |
5 (10%) |
8 (16%) |
0.037 |
||
- No adverse events linked to treatment were reported in the amisulpride group.
Conclusions
- A single 5 mg IV dose of amisulpride given intra‑operatively at the end of surgery was non‑inferior to 4 mg ondansetron in reducing the incidence and severity of PONV in patients undergoing supratentorial craniotomy.
Indian J Anaesth. 2026;70:358-65.
