Melatonin vs Pregabalin for Anxiolysis and Sedation

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221151
• Other study ID #: 1/2022ANET3-B
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2022
• Est. completion date: October 2, 2022

Study information

• Verified date: December 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety

Intervention

Drug:
• Melatonin
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
• Pregabalin
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
• Ondansetron 4 MG
before spinal anaesthesia

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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