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

Shivering Clinical Trial

Official title:

Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134895
• Other study ID #: 7240623MAANE
• Status: Recruiting
• Phase: Phase 4
• Start date: August 16, 2023
• Est. completion date: November 16, 2023

Study information

• Verified date: November 2023
• Source: Ziauddin University
• Contact: Muhammad Arif
• Phone: +92 331 3455112
• Email: muhammad.aarif[@]zu.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Shivering

Intervention

Drug:
• Tramadol with Ketamine
Tramadol with Ketamine is being provided randomly using prospective, double-blind
• Tramadol
Tramadol alone is being provided randomly using prospective, double-blind

Locations

Country	Name	City	State
Pakistan	Muhammad Arif	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of Shivering	Shivering will be graded as per the following criteria: 0= no shivering.; piloerection or peripheral vasoconstriction but no visible shivering.; muscular activity (visible muscular twitching) in only one muscle group; muscular (visible muscular twitching) activity in more than one muscle group but not generalized.; shivering involving the whole body	Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Secondary	Time to shivering	The time to shiver will be defined as the duration from the initiation of the intervention until the onset of observable shivering.	15 mins from the administration of the prophylactic drug
Secondary	Complications	Complications such as hypotension, nausea and vomiting, bradycardia, or hallucinations will be noted	Patients will be monitored from 15-45 mins from the administration of the prophylactic drug