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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06134895
Other study ID # 7240623MAANE
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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