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

NCT ID: NCT06134895

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2023-11-16

Brief Summary

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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.

Detailed Description

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Conditions

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Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tramadol with Ketamine

Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg

Group Type EXPERIMENTAL

Tramadol with Ketamine

Intervention Type DRUG

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

Tramadol

Tramadol 0.5mg/kg

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

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

Interventions

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Tramadol with Ketamine

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

Intervention Type DRUG

Tramadol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziauddin University

OTHER

Sponsor Role lead

Responsible Party

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Dr Muhammad Arif

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Arif

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University

Locations

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Muhammad Arif

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Arif

Role: CONTACT

+92 331 3455112

Facility Contacts

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Muhammad Arif

Role: primary

+92 331 3455112

Other Identifiers

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7240623MAANE

Identifier Type: -

Identifier Source: org_study_id

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