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To study the pharmacological and physical effects of adding Fentanyl as an adjuvant to hyperbaric Bupivacaine in spinal anesthesia.

Enhancing spinal anesthesia with intrathecal injection of Fentanyl as adjuvant to hyperbaric Bupivacaine. Pharmacological or physical effect? A randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063359
Enrollment
90
Registered
2024-02-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: K389- Disease of appendix, unspecified Health Condition 2: K389- Disease of appendix, unspecified Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 4: K37- Unspecified appendicitis Health Condition 5: K37- Unspecified appendicitis Health Condition 6: K37- Unspecified appendicitis

Interventions

Intervention1: Subarachnoid Block: Subarachnoid Block will be given in L4 - L5 vertebral space with 25G spinal needle in lateral position. Control Intervention1: 3ml of 0.5% Bupivacaine: 0.5% hyperba

Sponsors

Mahatma Gandhi University of medical sciences and technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective below umbilical surgeries under subarachnoid block. 2.Patients of either sex between 18-55years of age 3.Patient under ASA CLASS I/ II 4.Patients willing to give written and informed consent

Exclusion criteria

Exclusion criteria: 1.Patient under ASA CLASS III, IV & V 2.HIV, HbsAg, HCV positive patients 3.Non-consenting patients. 4.Patients with Local site sepsis or any contraindication for subarachnoid block.

Design outcomes

Primary

MeasureTime frame
To study the onset and duration of sensory and motor blockade, highest level of anesthesia and total duration of analgesia with bupivacaine alone or when either Fentanyl or saline is injected subsequent to Bupivacaine for spinal anesthesia. Timepoint: minutes—

Secondary

MeasureTime frame
1.To study the changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), arterial oxygen saturation on pulse oximetry (SpO2). 2.To assess the requirement of postoperative rescue analgesia. 3.To study the postoperative side effects viz Nausea, vomiting, Itching, Urinary retention, respiratory depression etc. Timepoint: hours—

Countries

India

Contacts

Public ContactDr Avnish Bharadwaj

Mahatma Gandhi University Of Medical Sciences and technology

avnishbharadwaj1@gmail.com9314882845

Outcome results

None listed

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