Prevention of Shivering Associated With Spinal Anesthesia
Dexmedetomidine Versus Ketamine to Prevent Shivering Associated With Intrathecal Anesthesia in Patients Undergoing Knee Arthroscopy:A Randomized, Controlled Double Blinded Study.
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2023
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 13, 2023
October 1, 2023
1 year
October 8, 2023
October 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of shivering
Incidence of shivering post intrathecal anesthesia is recorded
During operation time
Study Arms (3)
Group D (dexmedetomidine group)
ACTIVE COMPARATORGroup K (ketamine group)
ACTIVE COMPARATORGroup C (control group)
PLACEBO COMPARATORInterventions
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
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
If the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine
Eligibility Criteria
You may qualify if:
- \- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Essam Ez Abdelhakeem, Professor
Assiut University
- STUDY DIRECTOR
Seham Mo Moeen, Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mohammed Mohammed
Study Record Dates
First Submitted
October 8, 2023
First Posted
October 13, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
October 13, 2023
Record last verified: 2023-10