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A clinical trial to study the effect of Ketamine spray versus Dexmedetomidine spray at surgical site during closure in lumbar spine fixation surgery for postoperative pain relief

To compare the effect of Ketamine spray versus Dexmedetomidine spray at surgical site during closure in lumbar spine fixation surgery for postoperative pain relief - Prospective, Randomized, double blinded, placebo controlled study - Nil

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062613
Enrollment
45
Registered
2024-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Interventions

Intervention1: Ketamine spray: Will receive Ketamine 1 mg/kg diluted in normal saline to make 20 ml solution and is sprayed over the surgical site towards the end of the surgery Control Intervention1:

Sponsors

Institute of medical sciences banaras hindu university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Lumbar spine patients posted for spine instrumentation surgery. 2. Age group between 18 and 60 years.

Exclusion criteria

Exclusion criteria: 1. Refused to participate in the study. 2. A body mass index exceeding 30 kg/m2 3. Allergy to any studied medication 4. Hepatic or Renal insufficiency 5. Multiple level spine surgery or simultaneous/recent surgery 6. Antihypertensive medication with clonidine or other a2 agonists.

Design outcomes

Primary

MeasureTime frame
Duration of postoperative analgesia (VAS)Timepoint: 30mins,hours: 1,2,4,6,24

Secondary

MeasureTime frame
Total rescue analgesic requirement in 24hr. Any associated side effects like nausea /vomiting/sedation/shivering etc.Timepoint: 24 hours

Countries

India

Contacts

Public ContactDr Birju Manjhi

Institute of medical sciences

dryashacin1999@gmail.com9918424416

Outcome results

None listed

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