Melatonin vs Pregabalin for Anxiolysis and Sedation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05221151

Enrollment

Registered

2022-02-02

Start date

2022-01-30

Completion date

2022-10-02

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

melatonin, pregabalin

Brief summary

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

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).

Interventions

DRUGMelatonin

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

DRUGPregabalin

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

DRUGOndansetron 4 MG

before spinal anaesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026