Melatonin vs Pregabalin for Anxiolysis and Sedation
Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia
1 other identifier
interventional
78
1 country
1
Brief Summary
preoperative melatonin, pregabalin or both will be given to all patients preoperative
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 anxiety
Started Jan 2022
Shorter than P25 for phase_4 anxiety
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
First Submitted
Initial submission to the registry
January 7, 2022
CompletedStudy Start
First participant enrolled
January 30, 2022
CompletedFirst Posted
Study publicly available on registry
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2022
CompletedDecember 21, 2022
December 1, 2022
3 months
January 7, 2022
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
VAS
change of VAS of the patient on a scale from the night before surgery
on arrival to operating room then every 6 hours untill 48 hours
Ramsey Sedation scale
change of sedation of the patient on a scale from the night before surgery
on arrival to operating room then every 6 hours untill 48 hours
Study Arms (3)
melatonin
ACTIVE COMPARATOR26 patients will receive melatonin 10 mg
pregabalin
ACTIVE COMPARATOR26 patients will receive pregabalin 150 mg
melatonin and pregabalin
ACTIVE COMPARATOR26 patients will receive melatonin 5 mg plus pregabalin 75 mg
Interventions
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
Eligibility Criteria
You may qualify if:
- ASA I or II
- patients undergoing hip arthroplasty
- patient consent for spinal anaesthesia
- patient alert, concious and good mental condition
You may not qualify if:
- Patients with any neurolgical or psychiatric history before the procedure
- Patients with a history of chronic pain
- patients with known allergy to any of this study drugs
- patients have Any contraindication to neuraxial block.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, University Hospitals
Shibīn al Kawm, Menoufia, 32511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
January 7, 2022
First Posted
February 2, 2022
Study Start
January 30, 2022
Primary Completion
May 2, 2022
Study Completion
October 2, 2022
Last Updated
December 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share