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A clinical study to compare quality of sleep after surgery between dexmedetomidine and ketamine ( drugs used for sedation during surgery ) in obese patients undergoing gynaecological surgery under combined spinal anaesthesia

Comparison of postoperative sleep quality with dexmedetomidine versus ketamine in obese patients undergoing elective gynaecological surgery under central neuraxial block : A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096427
Enrollment
80
Registered
2025-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: 4- Measurement and Monitoring

Interventions

Intervention1: postoperative sleep quality with intraoperative dexmedetomidine infusion in obese patients undergoing gynaecological surgery under central neuraxial block: after achieving adequate derm

Sponsors

Lady Hardinge Medical College and associated hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2.BMI more than equal to 25 Kg/m² 3.Undergoing elective gynaecological surgery under central neuraxial block 4.ASA physical status I, II and III

Exclusion criteria

Exclusion criteria: 1.Known history of obstructive sleep apnoea (OSA) or use of continuous positive airway pressure (CPAP) 2.Patients with cognitive impairment or inability to assess sleep quality reliably, pre-existing neurological, psychiatric or sleep disorders 3.Chronic use of antidepressants, antipsychotics, opioids, sedatives, steroids or drug/alcohol abuse 4.Known allergy or contraindication to dexmedetomidine or ketamine

Design outcomes

Primary

MeasureTime frame
Mean ± standard deviation of Richards Campbell Sleep Questionnaire with dexmedetomidine versus ketamine in obese patients undergoing elective gynaecological surgery under central neuraxial blockTimepoint: Morning following first night after surgery—

Secondary

MeasureTime frame
Proportion of patients developing intraoperative adverse effects such as bradycardia, tachycardia, hypertension, hypotension and desaturation in both groups Timepoint: during the surgery;Proportion of patients having postoperative nausea and vomiting in both groupsTimepoint: 1 hour, 3 hours, 6 hours, 12 hours and 24 hours after surgery;Median (Interquartile range) Visual Analogue Scale score in both groupsTimepoint: 1 hour, 3 hours, 6 hours, 12 hours and 24 hours after surgery;Mean ± standard deviation of rescue analgesic consumption in both groupsTimepoint: first 24 hours after surgery;Median score (IQR) of total sleep time, sleep efficiency index and arousal index in both groupsTimepoint: Morning following first night after surgery;Correlation between Richards Campbell Sleep Questionnaire and polysomnography findings in both groupsTimepoint: Morining following first night after surgery—

Countries

India

Contacts

Public ContactShubham Joshi

Lady Hardinge Medical College and associated hospitals

ranjusingh1503@gmail.com9811151285

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026