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Comparison of two different doses of oral Melatonin in patients undergoing lower limb Orthopaedic surgeries to check anxiety before and after surgery and pain after surgery

Not Applicable
Conditions
Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified
Registration Number
CTRI/2022/05/042801
Lead Sponsor
Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients undergoing lower limb orthopaedic surgeries under Spinal anaesthesia.

Exclusion Criteria

1. contraindication to regional anaesthesia.

2. Major renal, hepatic or cardiovascular dysfunction.

3. known Psychiatric disorders like depression, schizophrenia, anxiety.

4. known allergy to Melatonin.

5. Pregnancy.

6. Language and communication difficulties.

7.Patients who refuse to participate in study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assess pre-operative Anxiety using STAI scale.Timepoint: 60-90 minutes prior to surgeries and just before shifting the patient to surgery. <br/ ><br>Then following up patients till 72 hours post-operatvely.
Secondary Outcome Measures
NameTimeMethod
1. pain using VAS in post operative period. <br/ ><br>2.Time to request first analgesic. <br/ ><br>3. total analgesic consumption of Paracetamol and Diclofenac sodium post-operatively. <br/ ><br>4.peri-operative quality of sleep. <br/ ><br>5.side effects, if any.Timepoint: upto 72 hours post-operatively.
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