A study comparing two groups of patients undergoing bilateral total knee replacement one receiving only injection dexamethasone and other receiving injection levosulpiride with injection dexamethasone to assess the effect for post operative nausea and vomiting prophylaxis.

To assess the efficacy of addition of intravenous levosulpiride to dexamethasone as prophylaxis for PONV in patients undergoing B/L TKR: a prospective, randomized, double blinded, controlled study". - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056491

Enrollment

100

Registered

2023-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Injection Levosulpiride: Injection Levosulpiride 25mg intravenously along with injection dexamethasone 8mg intravenously will be given one time 30 minutes after induction of anesthesia

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for bilateral knee replacement surgery of ASA grade 1 and 2 , for degenerative joint disease. 2. Patients with APFEL score of at least 1 or more.

Exclusion criteria

Exclusion criteria: ASA III, IV patients with severe illness 2. Patients with history of severe valular heart disease, vascular or conduction abnormalities 3. Known history of allergy to the study drugs 4. Any contraindication to spinal anesthesia or failure of spinal anesthesia necessitating general anesthesia 5. Patients with neurologic or cognitive disorders/ non cooperative patients/ patients with psychosis. 6. Patients with poor glycemic control HBA1c >8. 7. Severe hepatic or renal dysfunction 8. Intake of anti-emetics or steroids within last 24 hours of surgery 9. Patientâ??s refusal

Design outcomes

Primary

Measure	Time frame
Incidence of PONV Incidence of nausea Incidence of vomiting 2. Complete response of study drug (no nausea or vomiting or need of rescue drugs)Timepoint: Till 24 hours	—

Secondary

Measure	Time frame
Time of onset Time of severity & duration of PONV Severity of nausea Severity of vomiting Number of rescue antiemetic drugs requirements Pain assessment Side effects if anyTimepoint: Till 24 Hours	—

Countries

India

Contacts

Public ContactMansimrat Singh

Ivy hospital and health institute of life sciences

sunnyrupal@gmail.com9814359333

Outcome results

None listed

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