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Completed

NCT Number: NCT05221151

Melatonin vs Pregabalin for Anxiolysis and Sedation

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

Completed

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

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

Pregabalin

Drug

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

Ondansetron 4 MG

Drug

before spinal anaesthesia

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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