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Remifentanil versus fentanyl in emergency laparotomy.

Efficacy of remifentanil and fentanyl to alleviate the stress response in patients undergoing emergency laparotomy A comparative, randomized control trial. - R-FLExS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088329
Enrollment
68
Registered
2025-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K318- Other specified diseases of stomach and duodenum

Interventions

Intervention1: Remifentanil: Remifentanil will be used for perioperative analgesia. Induction Dose: 1mcg/Kg intravenously over 30-60 seconds. Maintenance Dose: 0.1-0.3 mcg/Kg/minute intravenous infusi

Sponsors

AIIMS Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patient aged 18-65 years, undergoing emergency laparotomy for gastrointestinal perforation under general anaesthesia

Exclusion criteria

Exclusion criteria: Patients with polytrauma requiring multiple procedures, uncontrolled hypertension, hypersensitivity to opioids, chronic use of opioid, severe cardiovascular disease, adrenal disease, endocrine or metabolic disease, hormonal or vasoactive drug history, and on inotropic support.

Design outcomes

Primary

MeasureTime frame
Plasma epinephrine, nor-epinephrine, cortisol and blood glucose levelsTimepoint: Before induction (T0), 5 minutes post intubation (T1), at incision (T2), 1 hour after incision (T3), and at the time of skin closure (T4).

Secondary

MeasureTime frame
Lymphocyte countsTimepoint: before induction (T0), at incision (T2), 1 hour after incision (T3), and at the time of skin closure (T4).;Mean arterial pressure (MAP), heart rate (HR), and perfusion index (PI)Timepoint: Before induction (T0), 5 minutes post intubation (T1), at incision (T2), 1 hour after incision (T3), and at the time of skin closure (T4).

Countries

India

Contacts

Public ContactSAURABH TRIVEDI

saurabh.tem@aiimsbhopal.edu.in

drst23@gmail.com7042461338

Outcome results

None listed

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