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Comparison of three medicines (Dexmedetomidine, Tramadol and normal saline) for prevention of shivering in females who are undergoing operation for childbirth under anaesthesia where only abdomen and legs will be made numb (spinal anaesthesia)

A study to compare the efficacy of intravenous dexmedetomidine, intravenous tramadol with placebo in prevention of post spinal anaesthesia shivering in patients undergoing caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051681
Enrollment
120
Registered
2023-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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: Dexmedetomidine: 0.5mcg/kg in 100ml normal saline, intravenous route, over 10 minutes after delivery of baby Control Intervention1: 1. Tramadol 2. Normal Saline: 1. 0.5 mg/kg in 100ml n

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy pregnant women

Exclusion criteria

Exclusion criteria: History of hypersensitivity to opiods or dexmedetomidine History of cardiovascular diseases, hypertension, pregnancy induced hypertension (PIH), Eclampsia, Antepartum Hemorrhage, Psychosis Patients who will develop shivering prior to administration of drugs Patients requiring general anaesthesia or sedation or any other major intraoperative complications Morbid obesity

Design outcomes

Primary

MeasureTime frame
Prevention of shiveringTimepoint: Intraoperatively every 5 minutes and postoperatively every 10 minutes—

Secondary

MeasureTime frame
To prevent perioperative complications if any like nausea, vomiting, sedation, hypotension, bradycardiaTimepoint: Intraoperatively every 5 minutes and postoperatively every 10 minutes—

Countries

India

Contacts

Public ContactDr Akarsh DS

PGIMS Rohtak

akarshds10@gmail.com9482029641

Outcome results

None listed

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