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To check the effects of three different doses of fentanyl with heavy bupivacaine in lower abdominal and lower limb surgeries

To assess the effects of three different doses of intrathecal fentanyl with hyperbaric bupivacaine in spinal anaesthesia for lower abdominal and lower extremities surgeries - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073204
Enrollment
75
Registered
2024-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Bupivacaine with fentanyl(25mcg): Patient undergoing for lower abdominal and lower extremities surgeries in spinal anaesthesia using intrathecal fentanyl dose 0.5ml (25 mcg) plus 2.8 ml

Sponsors

Dr Karan Goyal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists ASA grade I and II (except pregnancy or breastfeeding women) Patients who gave written informed consent Patients scheduled for elective lower abdominal and lower extremities surgeries under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: American Society of Anesthesiologists ASA grade III or greater Age less than 18 years, more than 60 years Emergency surgeries or procedures requiring immediate intervention Patients with significant medical conditions such as severe cardiovascular disease, respiratory insufficiency, or neurological disorders that contraindicate spinal anaesthesia •History of opioid dependence or substance abuse •Known allergies or hypersensitivity to fentanyl, hyperbaric bupivacaine, or any components of the study medications •Patients with coagulation disorders or receiving anticoagulant therapy that increases the risk of bleeding complications associated with spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To explore the dose-response relationship between intrathecal fentanyl and hyperbaric bupivacaine regarding anaesthesia quality and durationTimepoint: Every 3 min for 15 min then every 15 min till recovery 2 months—

Secondary

MeasureTime frame
To identify any potential predictors of optimal dose selection for intrathecal fentanyl based on individual patient factors & surgical requirementsTimepoint: Every 3 min for 15 min then every 15 min till recovery 2 months—

Countries

India

Contacts

Public ContactDr Satyen Verma

Varun Arjun Medical College and Rohilkhand Hospital

mirbashir96@gmail.com9682536855

Outcome results

None listed

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