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The effect of administration of a very minimal amount of ketamine (a medicine used commonly during an operation) on mood changes that happen after the surgery in patients undergoing an operation for the spinal cord compression involving the neck.

Effect of Intraoperative administration of Sub-anaesthetic doses of Ketamine on Post-Operative Depression in patients with degenerative Cervical Spondylotic Myelopathy (CSM) undergoing decompressive surgeries such as Cervical Corpectomy, Discectomy and Laminectomy. - SAK-POD Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035832
Enrollment
140
Registered
2021-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: M471- Other spondylosis with myelopathy

Interventions

Intervention1: Ketamine: Subanaesthetic dose of Ketamine (0.5mg/Kg) given as initial bolus over 15 minutes, soon after induction of anaesthesia, followed by an infusion of Ketamine (0.1mg/kg/hr) throu

Sponsors

Deyya Anil Amrutha Raj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status I - III 2. Age group of patients with 18 - 70 years, of both the genders 3. Undergoing decompressive surgery for Cervical spondylotic Myelopathy (CSM) 4. No cognitive impairment or without a history of depression, currently not on any anti-depressant medication

Exclusion criteria

Exclusion criteria: 1. Patients with chronic kidney disease with a high serum creatinine levels ( >1.7mg/dL) 2. Patients who already have a known history of Major Depressive disorder on treatment. 3. History of major psychiatric illness, currently on treatment 4. History of allergy to ketamine 5. Body Mass Index â?? greater than 35

Design outcomes

Primary

MeasureTime frame
To study the effect of low dose ketamine on post-operative depression using Patient Health Questionnaire -9 at 48 hours after the surgery and on the 7th post-operative day.Timepoint: 48 hours, 7 days

Secondary

MeasureTime frame
1. To compare the pain scores between the groups in the first 24 hours of post-operative period. 2. To estimate the amount of rescue analgesic requirement during the first 24 hours after the surgery. 3. To estimate the incidence of side effects between groups during the first 24 hours of post operative period.Timepoint: 24 hours, 24 hours, 24 hours

Countries

India

Contacts

Public ContactDeyya Anil Amrutha Raj

Christian Medical College, Vellore.

ramamani@cmcvellore.ac.in9443753184

Outcome results

None listed

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