Role of Intravenous Dexmedetomidine in Reducing Shivering After Shivering Cesarean Section Due to Spinal Anesthesia
Effects of Intravenous Dexmedetomidine on Shivering After Cesarean Delivery Under Neuraxial Anesthesia - A Randomized Control Trial
2 other identifiers
interventional
60
1 country
1
Brief Summary
"After spinal anesthesia, some patients may experience shivering, which can be uncomfortable and even lead to complications. Dexmedetomidine is a medication that can help prevent or reduce this shivering. Dexmedetomidine helps to:
- 1.Reduces shivering and discomfort.
- 2.Improves patient comfort and satisfaction.
- 3.Regulates body temperature.
- 4.Safe and effective.
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 Dec 2023
Shorter than P25 for phase_2
1 active site
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
Study Start
First participant enrolled
December 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2024
CompletedFirst Submitted
Initial submission to the registry
November 21, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedDecember 2, 2024
November 1, 2024
6 months
November 21, 2024
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shivering
Crossley and Mahajan grading of intraoperative shivering Grade 0: no shivering grade 1:no visible muscle activity but piloerection, peripheral vasoconstriction, or both present grade 2: muscular activity in one muscle group grade 3: muscle activity in one than more muscle group
3 minutes following infusion
Study Arms (2)
Intervention group
ACTIVE COMPARATORReceived intravenous dexmedetomidine
Control group
PLACEBO COMPARATORcontrol group receive normal saline
Interventions
intravenous dexmedetomidine given in form of 100ml infusion over 10 minutes
Eligibility Criteria
You may qualify if:
- Elective Cesarean section
- Age limit 18 to 35 years
- ASA II
You may not qualify if:
- Emergency cesarean delivery
- hypersensitive to dexmedetomidine
- Pateint with hear, renal, or hepatic diseases requiring follow up
- Pre-eclemptic pateint
- Patient with GA
- Combined spinal epidural anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liaquat National Hospital and Medical College
Karachi, Sindh, Pakistan
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ghulam Fatima kharl
Liaquat national hospital and medical college
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2024
First Posted
December 2, 2024
Study Start
December 21, 2023
Primary Completion
June 15, 2024
Study Completion
June 21, 2024
Last Updated
December 2, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Reasons of why individual participant data (IPD) may not be shared: 1. \*Patient confidentiality\*: Sharing IPD could compromise patient confidentiality 2. \*Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. 3. \*Data storage and security\*: Sharing IPD requires ensuring the security and integrity of the data, which can be a significant technical challenge.