Health Condition 1: K31- Other diseases of stomach and duodenum Health Condition 2: K35-K38- Diseases of appendix Health Condition 3: K40-K46- Hernia Health Condition 4: K55-K64- Other diseases of intestines Health Condition 5: K65-K68- Diseases of peritoneum and retroperitoneum Health Condition 6: K70-K77- Diseases of liver Health Condition 7: K80- Cholelithiasis Health Condition 8: K81- Cholecystitis Health Condition 9: K85- Acute pancreatitis Health Condition 10: K80-K87- Disorders of gallbla
Conditions
Interventions
Intervention1: postoperative sleep quality with oral zolpidem tablet in adult patients undergoing elective surgery under general
anaesthesia: Patients will receive Oral Zolpidem 5mg tablet, 9 PM night
Sponsors
Lady Hardinge Medical College and SSKH
Eligibility
Inclusion criteria
Inclusion criteria: 1. ASA physical status I-II 2. Scheduled for elective laparoscopic abdominal surgery under general anaesthesia of minimum duration 1 hour and maximum duration 3 hours
Exclusion criteria
Exclusion criteria: 1. Known history of obstructive sleep apnea (OSA) or use of continuous positive airway pressure (CPAP) 2. Pre-existing neurological, psychiatric, cognitive impairment or sleep disorders 3. Chronic use of antidepressants, antipsychotics, opioids, sedatives, or steroids or drug/alcohol abuse 4. Known allergy to zolpidem or melatonin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean ± standard deviation of Richards-Campbell Sleep Questionnaire to assess subjective postoperative sleep quality in patients receiving oral zolpidem versus melatonin after elective surgery under general anaesthesia.Timepoint: 6am on Post-operative day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of intraoperative adverse events, including bradycardia and hypotension, expressed as proportions in each groupTimepoint: during the surgery;The median (interquartile range) of Visual Analogue Scale for Anxiety (VASA) scores to quantify postoperative anxiety levelsTimepoint: morning of the surgery and morning following first night after surgery;The mean ± standard deviation of rescue analgesic consumptionTimepoint: first 24 hours following surgery;Median score (IQR) of polysomnography to assess objective sleep quality.Timepoint: morning of the surgery and morning following first night after surgery;correlation between subjective (RCSQ) and objective (polysomnography) measures of postoperative sleep quality.Timepoint: morning of the surgery and morning following first night after surgery | — |
Countries
India
Contacts
Public ContactPrakash Aaditya
Lady Hardinge Medical College and SSKH
Outcome results
None listed