Prevention of Shivering Associated With Spinal Anesthesia

NCT ID: NCT06082076

Last Updated: 2023-10-13

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-12-31

Brief Summary

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The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy

Detailed Description

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Conditions

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Shivering, Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group D (dexmedetomidine group)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Patients will receive dexmedetomidine 0.5 mcg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia

Group K (ketamine group)

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Patient will will receive ketamine 0.5 mg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia

Group C (control group)

Group Type PLACEBO_COMPARATOR

Meperidine

Intervention Type DRUG

If the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine

Interventions

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Dexmedetomidine

Patients will receive dexmedetomidine 0.5 mcg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia

Intervention Type DRUG

Ketamine

Patient will will receive ketamine 0.5 mg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia

Intervention Type DRUG

Meperidine

If the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria

* Patient refusal Aged less than 18 years or lesser than 150 cm in height Pregnant woman Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases, ASA III-IV Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Galal Mohammed Mohammed

Mohammed Mohammed

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essam Ez Abdelhakeem, Professor

Role: STUDY_DIRECTOR

Assiut University

Seham Mo Moeen, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ahmed Ga Mohammed, Resident

Role: CONTACT

+201091339220

Other Identifiers

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Shivering and anesthesia

Identifier Type: -

Identifier Source: org_study_id

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