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Comparison of Ketamine, Lidocaine and Dexmedetomidine Regimen compared to opioid based general anaesthesia in Laparotomy Surgeries.

Efficacy of KeLiDex Regimen Compared to Opioid -based General Anaesthesia in Laparotomy Surgeries: A Randomised, Single-blind Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069691
Enrollment
28
Registered
2024-06-28
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: O- Medical and Surgical

Interventions

Intervention1: KeLiDex: Ketamine, Lignocaine and Dexmedetomidine: Loading dose of Ketamine-0.5mg/kg and Lignocaine- 1 mg/kg in 10 ml volume syringes. The bolus syringes will be coded and kept in the s

Sponsors

All India Institute of Medical Sciences, Deoghar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Body mass index: 18.5-29.99 kg/m2. Elective Laparotomy surgeries. American Society of Anesthesiologists physical status (ASA-PS) I and II.

Exclusion criteria

Exclusion criteria: Patient refusal. Patients with a diagnosis of shock and sepsis. Patients with severe organ failure requiring support like Respiratory, Liver, Cardiac, Renal. Patients with uncontrolled hypertension greater than 150/90 mmHg. Patients with suspected or known autonomic neuropathy. A special group of participants. Preoperative bradycardia or Atrioventricular block Intraoperative circumstances like vasopressor or vasodilation infusion, if required or requiring hypotensive anesthesia, and airway management requiring unconventional techniques and modification of induction and oxygenation. Laryngoscopy and endotracheal intubation time greater than 30 seconds.

Design outcomes

Primary

MeasureTime frame
To compare intraoperative hemodynamic variations (as a surrogate of adequate analgesia under controlled anaesthetic depth ) between the groups. Parameters- Heart rate, blood pressure, respiratory rate, oxygen saturation Timepoint: 5 minutes before laryngoscopy, immediately after intubation, 5 minutes and 10 minutes after intubation, at the time of incision and 15 minutes thereafter. Vitals will be again noted just before and at 5 minutes post injection of reversal.

Secondary

MeasureTime frame
To compare postoperative 24-hour pain and rescue analgesics consumption.Timepoint: Numeric Rating Scale at rest and on movement at 10 minutes, 30 minutes, 60 minutes, 120 minutes, 6 hours, 12 hours and 24 hours in the postoperative period. Time and dose of epidural top ups in the intraoperative and postoperative period.;To compare the incidence of tearing during laryngoscopy and intubation.Timepoint: At the time of laryngoscopy and endotracheal tube intubation.;To compare the post extubation seadtion and discharge readiness from Post Anaesthetic care unit. Parameters- time to reach Modified Aldrete Score, Richmond Agitation Sedation Scale, Likert scale for Post operative Nausea and Vomiting.Timepoint: Modified Aldrete Score measured every 5 minutes till it reaches a score of greater than or equal to 9 out of 10. Richmond Agitation Sedation Scale will be noted at 5 minutes, 10 minutes, 30 minutes, 60 minutes, 120 minutes, 6 hours, 12 hours, 24 hours after extubation.

Countries

India

Contacts

Public ContactDr Sanjay Kumar

All India Institute of Medical Sciences, Deoghar

drsanjayaiims2012@gmail.com7063956225

Outcome results

None listed

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