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Opioid Free Anaesthesia (OFA): Fentanyl vs Ketodex, a randomised controlled study

A single center, randomised controlled, double blinded clinical study on opioid free anaesthesia in patients undergoing minimally invasive abdominal and pelvic surgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095164
Enrollment
84
Registered
2025-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: Fentanyl: Given at induction 2 mcg per kilo followed by 1 mcg per kilo every hour till end of procedure Control Intervention1: Dexmedetomine 100 mcg and ketamine 50 mg diluted with 48 m

Sponsors

SIMS Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of American society of anaesthesiology grade 1 and 2 Patients weighing between 40 and 80 kilos All genders Patients admitted for minimally invasive abdominal and pelvic surgeries Patients willing to participate in the study

Exclusion criteria

Exclusion criteria: Patients of American society of anaesthesiology grades 3 and above Pregnant and lactating women Patients with allergies to any of the drugs- general and local anaesthetic agents being used Patients with h/o neuromuscular disorders, malignant hyperthermia or susceptible individuals Patients with any degree of heart block or with pacemaker Minimally invasive surgeries getting converted to open surgeries Patients with anticipated possible difficult airway Patients participating in any other clinical study Patients not willing to participate in this study

Design outcomes

Primary

MeasureTime frame
To compare intraoperative combination of dexmedetomidine and ketamine (ketodex) with that of intraoperative fentanyl in terms of post operative analgesia by means of Visual Analogue Scale (VAS)Timepoint: Immediate post op, every hour till 6 hours postoperative

Secondary

MeasureTime frame
To monitor & quantify adverse effects of ketodex in terms of sedation, bradycardia, hypotension & emergence delirium To quantify efficacy of analgesia of ketodex in terms of requirement of postoperative rescue analgesiaTimepoint: postoperative period immediately & every hour till 6 hours post operative

Countries

India

Contacts

Public ContactDr Balachandran

SIMS Hospitals

balaab8@gmail.com9840680680

Outcome results

None listed

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