To compare the efficacy of dexmedetomidine and fentanyl as adjuncts to intrathecal 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing total abdominal hysterectomy

Comparison of Fentanyl and Dexmedetomidine as adjuvants to hyperbaric levobupivacaine (0.5%) in elective total abdominal hysterectomy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056887

Enrollment

Registered

2023-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: N711- Chronic inflammatory disease of uterus

Interventions

Intervention1: Levobupivacaine with fentanyl in spinal anaesthesia: 3ml 0.5% hyperbaric levobupivacaine and 25 mcg fentanyl(0.5ml) administered via intrathecal route, single dose. Effects monitored fo

Eligibility

Inclusion criteria

Inclusion criteria: Patient’s consent Patients posted for elective total abdominal hysterectomy at Rajendra Institute of Medical Sciences ASA physical status I & II

Exclusion criteria

Exclusion criteria: Patient’s with contradictions to spinal anaesthesia, neurological diseases, allergy or intolerance to local anaesthetic agents or other agents used for the study. Presence of co-morbidities like severe anaemia, uncontrolled diabetes mellitus, asthma, uncontrolled hypertension, severe cardiac disease Patient’s belonging to ASA III and above

Design outcomes

Primary

Measure	Time frame
1. Comparison of sensory block achieved at T10 level after induction. 2. Duration of sensory block 3. Onset of motor block 4. Duration of motor blockTimepoint: 1. From the time of induction to time taken to reach T10 dermatome. 2. From the time of induction till patient feels the sensation at S1 dermatome. 3. From the time of induction till patient attains modified Bromage scale grade 1 motor blockage. 4. From the time of induction till patient attended complete motor recovery.	—

Measure

Time frame

1. Comparison of sensory block achieved at T10 level after induction. 2. Duration of sensory block 3. Onset of motor block 4. Duration of motor blockTimepoint: 1. From the time of induction to time taken to reach T10 dermatome. 2. From the time of induction till patient feels the sensation at S1 dermatome. 3. From the time of induction till patient attains modified Bromage scale grade 1 motor blockage. 4. From the time of induction till patient attended complete motor recovery.

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Secondary

Measure	Time frame
1. To calculate the total duration of analgesia & consumption of rescue analgesia. 2. To study the hemodynamic changes like HR, SBP, DBP, MAP, RR side effects & complications, if any.Timepoint: 1. Total rescue analgesia forfirst 24hours. 2. Hemodynamic changes every 3 mins till first 15mins, every 5 mins for 1hr, every hourly for first 6 hours, then 6 hourly for first 24hours. 3. Complications if any for first 24hours.	—

Measure

Time frame

1. To calculate the total duration of analgesia & consumption of rescue analgesia. 2. To study the hemodynamic changes like HR, SBP, DBP, MAP, RR side effects & complications, if any.Timepoint: 1. Total rescue analgesia forfirst 24hours. 2. Hemodynamic changes every 3 mins till first 15mins, every 5 mins for 1hr, every hourly for first 6 hours, then 6 hourly for first 24hours. 3. Complications if any for first 24hours.

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Countries

India

Contacts

Public ContactDr Saurabh Suman

Rajendra Institute of Medical Sciences

bharati.bediya@gmail.com9599277395

Outcome results

None listed

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