Melatonin vs Pregabalin for Anxiolysis and Sedation

December 19, 2022 updated by: mostafa saieed fahim mansour, Menoufia University

Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia

preoperative melatonin, pregabalin or both will be given to all patients preoperative

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete aseptic technique . The patient was returned to the supine position for 15 min then to lateral position with operative side up.

HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal injection as time zero.

Hypotension (SAP<100 mmHg or <80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR (≥60 bpm).

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 32511
        • Faculty of Medicine, University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I or II
  • patients undergoing hip arthroplasty
  • patient consent for spinal anaesthesia
  • patient alert, concious and good mental condition

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: melatonin
26 patients will receive melatonin 10 mg
Drug: Melatonin
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
Drug: Ondansetron 4 MG
before spinal anaesthesia
Active Comparator: pregabalin
26 patients will receive pregabalin 150 mg
Drug: Ondansetron 4 MG
before spinal anaesthesia
Drug: Pregabalin
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
Active Comparator: melatonin and pregabalin
26 patients will receive melatonin 5 mg plus pregabalin 75 mg
Drug: Melatonin
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
Drug: Ondansetron 4 MG
before spinal anaesthesia
Drug: Pregabalin
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: on arrival to operating room then every 6 hours untill 48 hours
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
Time Frame: on arrival to operating room then every 6 hours untill 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2022

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

October 2, 2022

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 22, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2022ANET3-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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