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A trail to compare caffeine and lactulose to restore bowel function after general anesthesia - CAFLAC trail

Oral caffeine versus lactulose for enhancing gastrointestinal recovery in patients after elective abdominal surgeries under general anesthesia - CAF-LAC TRAIL - A randomised controlled study - CAF-LAC Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106618
Enrollment
130
Registered
2026-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K560- Paralytic ileus

Interventions

Intervention1: Intervention Group (Group A Oral Caffeine): Participants randomized to the intervention arm will receive oral caffeine 100 mg twice daily. The first dose will be administered 6 hours

Sponsors

Dr Nikhil B
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 65 years Undergoing elective abdominal surgery under general anesthesia ASA physical status I III Able to tolerate oral intake postoperatively Expected hospital stay more than 24 hours Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: History of inflammatory bowel disease Patients undergoing bowel resection and anastomosis Known allergy or intolerance to caffeine or lactulose Patients on regular laxatives or prokinetics Severe hepatic, renal, or cardiac dysfunction Pregnant or lactating women Patients with caffeine dependence (greater than 400 mg/day intake)

Design outcomes

Primary

MeasureTime frame
Time to first bowel movement after surgeryTimepoint: Measured in hours from the end of surgery until the first documented bowel movement, assessed up to 120 hours (5 days) postoperatively or until discharge, whichever occurs earlier

Secondary

MeasureTime frame
Time to first flatus Time to first stool passage Time to tolerance of oral feeding Duration of hospital stayTimepoint: assessed up to 120 hours postoperatively or until discharge

Countries

India

Contacts

Public ContactDr Nikhil B

AIIMS GORAKHPUR

dr.dharmendrapipal2007@gmail.com9602541730

Outcome results

None listed

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