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Comparision of the efficacy of intravenous ketodex, ketamine with lignocaine and fentanyl for spine surgery in adult patients

To Compare the Efficacy of Intravenous Ketodex, Ketamine with Lignocaine and Fentanyl Infusion on Postoperative Analgesia in Adult Patients Undergoing Thoracolumbar Spine Surgery A Randomized Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083348
Enrollment
93
Registered
2025-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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: GROUP KETODEX(KD) AND GROUP KETAMINE AND LIGNOCAINE (KL): Group KD (KETODEX): IV infusion of 1 mg/kg inj. Ketamine iv and 1mcg/kg inj.dexmedetomidine iv for 10 minute beforeinduction .

Sponsors

AIIMS BHOPAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ina) 18 to 65 years, either gender. b) American Society of Anaesthesiologists physical status (ASA) I & II.

Exclusion criteria

Exclusion criteria: a) Patients refusing informed consent. b) Patients not extubated after surgery. c) Patients who are with the known allergic history to any of the study drugs. d) Patients who are pregnant e) Surgical duration more than 4 hours. f) Patients with known psychiatric illness g) Patients who are on treatment for chronic pain.

Design outcomes

Primary

MeasureTime frame
Primary: 1. To comparatively evaluate the visual analogue scale (VAS) score between the groups just after extubation, 2 hours ,4hours ,8 hours ,12hours and 24 hours. 2. To comparatively evaluate the emergence time and time taken to obtain the modified Aldrete score of 9 or more between the groups Timepoint: 0,2,4,6,12,24 hrs

Secondary

MeasureTime frame
Secondary: 1. To comparatively evaluate the mean arterial pressure (MAP) and heart rate (HR) between groups during the induction, intubation and immediately after prone position. 2. To comparatively evaluate the time point for the first ask of analgesic after extubation between the groups. 3. To comparatively evaluate the total requirement of rescue analgesia and perioperative total opioid consumption between the groups. 4. To comparatively evaluate the complications associated with infusions like bradycardia, hypotension, hypertension, sedation, nausea and vomiting in post operative period.Timepoint: 0,2,4,6,12,24 hrs

Countries

India

Contacts

Public ContactDr Ashutosh Kaushal

All India Institute of Medical Sciences

drashutosh.kaushal@gmail.com8765515521

Outcome results

None listed

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