Prevention of Shivering Associated With Spinal Anesthesia
Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06082076
Collaborator
(none)
90
3
13
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dexmedetomidine Versus Ketamine to Prevent Shivering Associated With Intrathecal Anesthesia in Patients Undergoing Knee Arthroscopy:A Randomized, Controlled Double Blinded Study.
Anticipated Study Start Date
:
Nov 1, 2023
Anticipated Primary Completion Date
:
Nov 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group D (dexmedetomidine group)
|
Drug: 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
|
| Active Comparator: Group K (ketamine group)
|
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
|
| Placebo Comparator: Group C (control group)
|
Drug: Meperidine
If the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine
|
Outcome Measures
Primary Outcome Measures
- Incidence of shivering [During operation time]
Incidence of shivering post intrathecal anesthesia is recorded
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Director: Essam Ez Abdelhakeem, Professor, Assiut University
- Study Director: Seham Mo Moeen, Professor, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ahmed Galal Mohammed Mohammed,
Mohammed Mohammed,
Assiut University
ClinicalTrials.gov Identifier:
NCT06082076
Other Study ID Numbers:
- Shivering and anesthesia
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: