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Effects of fentanyl and dexmedetomidine as adjuvants with intrathecal hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries

Comparsion of effects of adjuvants fentanyl and dexmedetomidine with intrathecal hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries: a randomised control trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089299
Enrollment
96
Registered
2025-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: fentanyl or dexmeditomedine as adjuvants for hyperbaric levobupivacaine: Study population is divided into 3 groups A,B and C. Group A will receive 14mg hyperbaric levobupivacaine alon

Sponsors

Jawaharlal Nehru Institute of Medical Sciences, Imphal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 - 60 years undergoing infraumbilical surgeries 2. Patients who are categorised under ASA I and II 3. Patients who have signed a written informed consent form

Exclusion criteria

Exclusion criteria: Patients refusal 1. Pregnant women 2. Patients with spine deformities, local infection near the injection site 3. Patients with history of allergy to study drugs 4. Patients with abnormal coagulation profile

Design outcomes

Primary

MeasureTime frame
To determine the onset and duration of sensory and motor block of intrathecal hyperbaric levobupivacaine alone, hyperbaric levobupivacaine with fentanyl, and hyperbaric levobupivacaine with dexmedetomidineTimepoint: The level of sensory block will be assessed by pin prick method every minute after drug administration till 15 minutes from start, then every 15 minutes till the completion of surgery. Motor block will be assessed by Modified Bromage Scale every minute till Modified Bromage grade 3 is achieved. Then motor block assessed every hourly for 3 hours

Secondary

MeasureTime frame
Hemodynamic effects. Heart rate, blood pressure, oxygen saturationTimepoint: baseline, then every 5 minutes after administration of drug till the surgery ends;Total number of rescue analgesia requiredTimepoint: till 12 hours after completion of surgery;Analgesic profileTimepoint: 1. Visual Analog Scale at the end of surgery 2. Visual Analog Scale when patient asks for 1st rescue analgesic dose

Countries

India

Contacts

Public ContactKEISHAM UPENDRA SINGH

Jawaharlal Nehru Institute of Medical Sciences, Imphal

drupendrakeisham@rediffmail.com9436039203

Outcome results

None listed

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