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

Phase 4

Not yet recruiting

• Conditions: Chronic inflammatory disease of uterus,

• Registration Number: CTRI/2023/08/056887
• Lead Sponsor: Rajendra Institute of Medical Sciences

Brief Summary

Neuraxial blockade in the form of spinal anaesthesia has been a very popular choice of anaesthesia for a multitude of surgeries, extending from caesarean section to lower limb surgeries.

Many drugs starting from opioids, magnesium sulphate, vasopressors and alfa-2 adrenergic agomists like dexmedetomidine and clonidine have been tried as an adjunct to local anaesthestic to manage this problem of post operative pain.

Levobupivacaine is a member of the amino amide class of local anaesthetics. The mechanism of its action is by blockade of sodium ion channels through the nerve membrane. It is preferred over bupivacaine because of its lower incidence of intraoperative hypotension.

Fentanyl is a synthetic short acting opioid which acts centrally and thus widely used for pain control. Intrathecal fentanyl is usually used as an adjunct to local anaesthetics to increase anaesthesia and analgesia by its synergistic effects.

Dexmedetomidine, on the other hand, is a new selective alpha 2 agonist, which has not only analgesic and sedative properties but also has sympatholytic activity.

In this study, our aim is to compare the efficacy of fentanyl and dexmedetomidine added to intrathecal 0.5% hyperbaric levobupivacaine in patients undergoing total abdominal hysterectomy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-22
• Study Start: 2023-08-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Comparison of sensory block achieved at T10 level after induction.	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.
2. Duration of sensory block	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.
3. Onset of motor block	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.
4. Duration of motor block	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rajendra Institute of Medical Sciences; 🇮🇳 Ranchi, JHARKHAND, India

Rajendra Institute of Medical Sciences

🇮🇳Ranchi, JHARKHAND, India

DR SUBHADEEP GUHA

Principal investigator

8617383944

pointersubho@gmail.com