MedDataX Logo

Melatonin vs Pregabalin for Anxiolysis and Sedation

NCT ID: NCT05221151

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2022-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

melatonin pregabalin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

melatonin

26 patients will receive melatonin 10 mg

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Ondansetron 4 MG

Intervention Type DRUG

before spinal anaesthesia

pregabalin

26 patients will receive pregabalin 150 mg

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

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

Ondansetron 4 MG

Intervention Type DRUG

before spinal anaesthesia

melatonin and pregabalin

26 patients will receive melatonin 5 mg plus pregabalin 75 mg

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Pregabalin

Intervention Type DRUG

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

Ondansetron 4 MG

Intervention Type DRUG

before spinal anaesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin

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

Intervention Type DRUG

Pregabalin

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

Intervention Type DRUG

Ondansetron 4 MG

before spinal anaesthesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Menoufia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

mostafa saieed fahim mansour

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1/2022ANET3-B

Identifier Type: -

Identifier Source: org_study_id