Melatonin vs Pregabalin for Anxiolysis and Sedation

Study Overview
=================
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).

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

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Drug: Melatonin
* Drug: Pregabalin
* Drug: Ondansetron 4 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: melatonin<br>26 patients will receive melatonin 10 mg | Drug: Melatonin<br>* In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery<br>Drug: Ondansetron 4 MG<br>* before spinal anaesthesia<br>|
| Active Comparator: pregabalin<br>26 patients will receive pregabalin 150 mg | Drug: Pregabalin<br>* In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery<br>Drug: Ondansetron 4 MG<br>* before spinal anaesthesia<br>|
| Active Comparator: melatonin and pregabalin<br>26 patients will receive melatonin 5 mg plus pregabalin 75 mg | Drug: Melatonin<br>* In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery<br>Drug: Pregabalin<br>* In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery<br>Drug: Ondansetron 4 MG<br>* before spinal anaesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin, pregabalin