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Comparison of anaesthesia with and without the use of opioids in patients undergoing middle ear surgery

Comparison of efficacy of opioid-free anaesthesia with opioid-based anaesthesia in patients undergoing middle ear surgery:a randomised controlled study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069510
Enrollment
76
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: H662- Chronic atticoantral suppurative otitis media Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Group OF (Opioid-Free): Patients will receive non-opioid drugs intraoperatively i.e. dexmedetomidine infusion via intravenous route pre-induction at 0.5mcg/kg over 10 minutes and then a

Sponsors

University College of medical sciences and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consenting ASA grade I – II patients, aged 20-60 years, undergoing middle surgeries.

Exclusion criteria

Exclusion criteria: Patients with a history of PONV. Patients with history of chronic pain of any etiology or patients who are already on opioids. Patients having cognitive dysfunction with inability to comprehend questionnaires.

Design outcomes

Primary

MeasureTime frame
Incidence of PONV using PONV scoreTimepoint: At the end of 12th hour

Secondary

MeasureTime frame
1 Incidence of PONV 2 Pain intensity using NRS Pain at Rest & Cough 3 Total rescue analgesic consumption in the first 24 hours 4 Total rescue antiemetic consumption in the first 24 hours 5 Time to Aldrete score more than or equal to 9 (in mins) 6 QoR-15 score at the end of 24 hrs Timepoint: 1 Incidence of PONV at various time points at the end of 3rd 6th 12th 24th & 48th hr 2 Pain intensity using NRS Pain at Rest & Cough at the end of 3th 6th 12th 24th & 48th hr 3 Total rescue analgesic consumption in first 24 hours 4 Total rescue antiemetic consumption in first 24 hours 5Time to Aldrete score more than or equal to 9 (in mins) & wlll be recorded from the time patient is shifted to postoperative area from operation theatre 6 QoR-15 score at the end of 24 hrs

Countries

India

Contacts

Public ContactDr Geetanjali T Chilkoti

University College Of Medical Sciences and GTB Hospital

raoaditya83@gmail.com8800507657

Outcome results

None listed

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