A clinical trial to study and compare the effect of nefopam and tramadol on preventing and decreasing intensity of shivering in patients undergoing transuretheral resection of prostate under spinal anaesthesia

A double blinded randomized prospective trial of comparison between control and study group on the effect of Nefopam versus Tramadol on shivering scores after spinal anaesthesia in patients undergoing Transuretheral resection of prostate - nefo

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037499

Enrollment

Registered

2021-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Nefopam: Nefopam 0.15 mg/kg mixed into 100 ml isotonic saline, given over 15 min just prior to spinal anaesthesia Intervention2: Tramadol: Tramadol 0.5 mg/kg mixed into 100 ml isotonic

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with American Society of Anesthesiologists (ASA) class I or class II physical status 2. Afebrile

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2.Any coagulopathy disorder 3. History of allergic reactions to local anaesthetics 4. Patients with severe cardiac, respiratory, hepatic or renal diseases

Design outcomes

Primary

Measure	Time frame
To compare the incidence and intensity of shivering in patients undergoing TURP patientsTimepoint: Shivering monitoring and grading will be done at 15 minutes interval till end of surgery	—

Secondary

Measure	Time frame
To compare the temperature, sedation and mean arterial pressureTimepoint: Sedation, temperature and mean arterial pressure monitoring and grading will be done at 15 minutes interval till end of surgery	—

Countries

India

Contacts

Public ContactSwapnil Kumar Barasker

Sri Aurobindo Medical College and PG Institute, Indore

swapnilkbarasker@gmail.com8109101245

Outcome results

None listed

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