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Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering

NCT ID: NCT06722742

Last Updated: 2024-12-09

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

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-01-30

Brief Summary

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\*Ketamine:\* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.

\- \*Tramadol:\* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.

Detailed Description

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Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.

Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:

* Reduced discomfort and anxiety for the patient
* Improved patient satisfaction
* Reduced need for additional medications or interventions
* Faster recovery times

Conditions

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Shivering, Spinal Anesthesia

Keywords

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shivering Spinal anesthesia Ketamine Tramadol and Metclopromide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group K

Group K receive Inj: ketamine

Group Type ACTIVE_COMPARATOR

Ketamine only

Intervention Type DRUG

Inj: Ketamine given to group K following spinal anesthesia

Group T

Group T receive Inj: Tramadol

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

Inj Tramadol given to group T following spinal anesthesia

Interventions

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Ketamine only

Inj: Ketamine given to group K following spinal anesthesia

Intervention Type DRUG

Tramadol

Inj Tramadol given to group T following spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pateint for elective cesarean section
* Age 18 to 40 years
* ASA 1 and 2

Exclusion Criteria

* ASA 2 and 3
* Cesarean section requiring general anesthesia
* Hypersensitivity to Ketamine, Tramadol and Opiods
* History of cardiovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Liaquat National Hospital & Medical College

OTHER

Sponsor Role lead

Responsible Party

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Nazish Kanwal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nazish Dr Nazish Kanwal

Role: PRINCIPAL_INVESTIGATOR

Liaquat national hospital and medical college

Locations

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Liaquat National Hospital and Medical College

Karachi, Sindh, Pakistan

Site Status RECRUITING

Liaquat National Hospital and Medical College

Karachi, Sindh, Pakistan

Site Status RECRUITING

Liaquat National Hospital and Medical College

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Nazish Dr Nazish Kanwal

Role: CONTACT

Phone: 03292163092

Email: [email protected]

Shazor khan Khattak

Role: CONTACT

Phone: +92 340 2286119

Email: [email protected]

Facility Contacts

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Nazish Kanwal Dr Nazish Kanwal

Role: primary

Shazor Khan

Role: backup

Nazish Kanwal Dr nazish Kanwal

Role: primary

Shazor

Role: backup

Nazish Kanwal Dr Nazish kanwal

Role: primary

Shahzor Khan

Role: backup

Related Links

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https://pmc.ncbi.nlm.nih.gov/articles/PMC9685948/

The effect of ketamine versus tramadol on prophylactic post-spinal shivering in those patients undergoing orthopedic surgery: a prospective cohort study design, 2020 Ashebir Debalike Gemechu 1, Tsegaye Demeke Gebremedhin 1,✉, Andualem Assefa Andebiku 1,

Other Identifiers

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#882-2023-LNH-ERC

Identifier Type: -

Identifier Source: org_study_id