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ADVENT OF A NOVEL ANESTHETIC TECHNIQUE FOR ANAL SURGERY

MODERATE SEDATION VERSUS SPINAL ANESTHESIA FOR RE-EXPLORATION OF SURGICAL WOUND FOLLOWING INDEX SURGERY FOR COMPLEX ANAL FISTULA: A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/06/005884
Enrollment
60
Registered
2015-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- COMPLEX ANAL FISTULA PATIENTS WHO HAD UNDERGONE INDEX SURGERY AND THOSE WHO REQUIRE RE EXPLORATION AND CURETTAGE OF THE WOUNDS

Interventions

Intervention1: REGIONAL ANESTHESIA GROUP: 1.5 ml of 0.5% heavy bupivacaine (7.5 mg) + 0.5ml normal saline, intrathecally. 30 ml of local anesthetic mixture consisting of 15ml 0.25% bupivacaine and 15m

Sponsors

GTB HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to age group 18â??50 years of age Patients belonging to ASA I and II Complex anal fistula requiring multiple re-explorations of the surgical wounds.

Exclusion criteria

Exclusion criteria: Patients refusing consent for inclusion in study. Patient with known sensitivity against drugs to be used. Patient in whom re-exploration involves complex procedures like flap advancement. Difficult airway. Contraindications for MS, SA, surgery, or the drugs used in the study.

Design outcomes

Primary

MeasureTime frame
Proportion of operations successfully completed with designated anesthesia/sedation technique.Timepoint: APRIL 2015

Secondary

MeasureTime frame
Duration of stay in post anesthetic care unit (PACU).Timepoint: MEDIAN DURATION OF STAY;MS/ SA related complications.Timepoint: PERCENTAGE;Need for assisted ventilation/ intubation/ventilator support.Timepoint: MEAN/MEDIAN;Patient satisfactionTimepoint: FIVE POINT SATISFACTION SCALE;Proportion of patients requiring supplementation with local anesthesia (LA).Timepoint: PROPORTION;SURGEON SATISFACTIONTimepoint: FIVE POINT SATISFACTION SCALE;Time required for administration of MS/SATimepoint: MEDIAN TIME REQUIRED;Total amount of propofol consumed during the procedure.Timepoint: MEAN

Countries

India

Contacts

Public ContactSENTHIL KUMAR

UCMS AND GTBH

senthilkumarsubramani86@gmail.com8527121424

Outcome results

None listed

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