To assess the effects of three different doses of intrathecal fentanyl with hyperbaric bupivacaine in spinal anaesthesia for lower abdominal and lower extremities surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- To explore the dose-response relationship between intrathecal fentanyl and hyperbaric bupivacaine regarding anaesthesia quality and duration
Study Overview
Brief Summary
The study titled "Comparing the Effects of Different Doses of Intrathecal Fentanyl Combined with Hyperbaric Bupivacaine for Spinal Anaesthesia in Lower Abdominal and Lower Extremity Surgeries" will be conducted in department of Anaesthesia,
Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh 242307 focusing on elective lower abdominal and lower extremities surgeries under spinal anaesthesia.
A. The study will involve patients scheduled for elective surgeries requiring spinal anaesthesia, based on specific inclusion and exclusion criteria.
B. Each patient will undergo a thorough medical history review and provide written informed consent.
C. Participants will undergo a preoperative clinical and laboratory assessment.
D. Patients will be admitted one day prior to surgery.
E. Participants will be randomly allocated into three groups:
Group A: Intrathecal fentanyl 12.5 mcg with 0.5% hyperbaric bupivacaine.
Group B: Intrathecal fentanyl 25 mcg with 0.5% hyperbaric bupivacaine.
Group C: Intrathecal fentanyl 37.5 mcg with 0.5% hyperbaric bupivacaine.
F. The study will evaluate the effects on anaesthesia quality, onset, duration of sensory and motor block, hemodynamic stability, and adverse reactions. Data on vital signs, block duration, and side effects will be collected throughout the study.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
To explore the dose-response relationship between intrathecal fentanyl and hyperbaric bupivacaine regarding anaesthesia quality and duration
Time Frame: Every 3 min for 15 min then every 15 min till recovery | 2 months
Secondary Outcomes
- To identify any potential predictors of optimal dose selection for intrathecal fentanyl based on individual patient factors & surgical requirements(Every 3 min for 15 min then every 15 min till recovery)
Investigators
Dr Karan Goyal
Varun arjun medical college and rohilkhand hospital