Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section

NCT06134895 | Unknown Phase 4

• 1 other identifier: 7240623MAANE
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.

Conditions

Shivering

Keywords

Shivering; Anesthesia, Spinal; Caesarean

Outcome Measures

Primary Outcomes (2)

• Incidence of shivering

  Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering

  Patients will be monitored from 15-45 mins from the administration of the prophylactic drug

• Severity of Shivering

  Shivering will be graded as per the following criteria: 0= no shivering. 1. piloerection or peripheral vasoconstriction but no visible shivering. 2. muscular activity (visible muscular twitching) in only one muscle group; 3. muscular (visible muscular twitching) activity in more than one muscle group but not generalized. 4. shivering involving the whole body

  Patients will be monitored from 15-45 mins from the administration of the prophylactic drug

Secondary Outcomes (2)

• Time to shivering

  15 mins from the administration of the prophylactic drug

• Complications

  Patients will be monitored from 15-45 mins from the administration of the prophylactic drug

Study Arms (2)

Tramadol with Ketamine

EXPERIMENTAL

Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg

Drug: Tramadol with Ketamine

Tramadol

ACTIVE COMPARATOR

Tramadol 0.5mg/kg

Drug: Tramadol

Interventions

Tramadol with Ketamine DRUG

Tramadol with Ketamine is being provided randomly using prospective, double-blind

Tramadol with Ketamine

Tramadol DRUG

Tramadol alone is being provided randomly using prospective, double-blind

Tramadol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 to 40 years
• American Society of Anesthesiologist physical status I and II
• Pregnant female for lower segment caeserian section

You may not qualify if:

• Patients with Hypertension
• Patients with hypo- or hyperthyroidism
• Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
• An initial body temperature 38.00C or, 36.0oC assessed by thermometer

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Muhammad Arif

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

Tramadol; Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Muhammad Arif

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Arif

CONTACT

+92 331 3455112; muhammad.aarif@zu.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: November 18, 2023
• Study Start: August 16, 2023
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)