Melatonin vs Pregabalin for Anxiolysis and Sedation

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05221151

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Drug: Melatonin Drug: Pregabalin Drug: Ondansetron 4 MG	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

May 2, 2022

Anticipated Study Completion Date :

Jun 2, 2022

Arms and Interventions

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 gabapentin 600 mg	Drug: Pregabalin 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: melatonin and pregabalin 26 patients will receive melatonin 5 mg plus gabapentin 300 mg	Drug: Melatonin In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery Drug: Pregabalin In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery Drug: Ondansetron 4 MG before spinal anaesthesia

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 gabapentin 600 mg

Drug: Pregabalin

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: melatonin and pregabalin

26 patients will receive melatonin 5 mg plus gabapentin 300 mg

Drug: Melatonin

In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery

Drug: Pregabalin

In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery

Drug: Ondansetron 4 MG

before spinal anaesthesia

Outcome Measures

Primary Outcome Measures

VAS [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
Ramsey Sedation scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, University Hospitals	Shibīn Al Kawm	Menoufia	Egypt	32511

Sponsors and Collaborators

Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mostafa saieed fahim mansour, lecturer, Menoufia University

ClinicalTrials.gov Identifier:

NCT05221151

Other Study ID Numbers:

1/2022ANET3-B

First Posted:

Feb 2, 2022

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by mostafa saieed fahim mansour, lecturer, Menoufia University

melatonin

pregabalin

Additional relevant MeSH terms:

Pregabalin

Ondansetron

Melatonin

Study Results

No Results Posted as of Apr 6, 2022