comparison of low dose clonidine and dexmedetomidine as a supportive agentto levobupivacaine in spinal anaesthesia

Phase 2/3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/11/060123

Lead Sponsor: Department of Anaesthesiology School of Medical Sciences and Research Sharda University.

Brief Summary: Centralneuraxial blockade is the most popular technique of anaesthesia for lowerlimb surgeries. It is having several advantages like easy technique, economicand provides good quality of anesthesia. It decreases blood loss, avoid risk ofintubation and aspiration, provides early ambulation Bupivacaine ismost commonly used local anaesthetic drug for spinal anaesthesiabut cardiotoxicity is the limiting factor. Levobupivacaine is having similar clinical profile with less cardio toxicitythan Bupivacaine is gaining popularity

It has demonstrated less affinity and strength of inhibitory effect onthe inactivated state of cardiac sodium channels than the Bupivacaine and fasterprotein binding rate. Toprovide good quality of intra operative anesthesia with postoperative analgesia different additives like Opioids, Ketamine, Midazolam, Neostigmine andÎ±2adrenergic agonist are usedAlpha-2adrenergic agonists have both analgesic and sedative properties when used as adjuvants to regionalanesthesia. By action at the Î±2-receptor in spinal and supraspinal sites, they potentiatethe effect of local anesthetics and allow a decrease in the required doses. Thesesalutary effects are achieved without causing respiratory depression orexcessive sedation. Clonidine is aselective partial Î±-2 adrenergic agonist provides effective, prolonged anddose dependent analgesia with a consequently decreased requirement ofsupplemental analgesics. The Î±2 adrenergic agonist clonidine has a variety of different actions,including the ability to potentiate the effects of local anesthetics. However, unlikespinal opioids, clonidine does not produce pruritis or respiratory depression. Dexmedetomidine,a highly selective Î±2 adrenergic agonist has emerged as a valuable adjunct toregional anesthesia and analgesia. It has become of the frequently used drugs,due to its hemodyanamic, sedative, anxiolytic, analgesic, neuroprotective andanaesthetic sparingeffects. Extensive searchof literature reveals that though the studies have been conducted withour additives with the drug bupivacaine, but a specific study comparing theadditive effect of both the drugs with the recently introduced drugLevobupivacaine and a suitable dose required intrathecally has not doneextensively. Therefore, the present study is designed to compare the effect ofintrathecal clonidine and dexmedetomidine as an adjuvant to Levobupivacaine insubarachnoid block. The specificoutcome measures to define the performance of our study will primarilyinclude comparing the effect of both the adjuvant drugs administered on theduration of motor and sensory blockade.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

1.Patient scheduled for surgery under subarachnoid block 2.Age 18-60 years 3.Both genders 4.ASA grade I and II.

Exclusion Criteria

1.Morbid obesity BMI>30kg permeter square 2.Patient with history of adverse response to study drugs 3.Patient with pre-existing neurological or spinal disease cardiovascular disease renal hepatic or any other systemic disease 4.Pregnant females 5.Coagulopathy or bleeding diathesis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of low dose intrathecal clonidine versus dexmedetomidine as anadjuvant to 0.5 percentage hyperbaric levobupivacaine in subarachnoid block in respect to	Post operative period
1.To compare the time of onset & duration of sensory blockade assessed by pinprick & Visual Analog Score VAS respectively.	Post operative period
2.To compare the time of onset & duration of motor blockade assessed by modified Bromage scale	Post operative period

Secondary Outcome Measures

Name	Time	Method
Changes in vitals parameters heart rate noninvasive blood pressure & oxygen saturation SPo2	2.Requirementoffirst analgesicrescueinpostoperativeperiodin thefirst 24hours.

Trial Locations

Locations (1): Sharda Hospital Sharda University
🇮🇳
Nagar, UTTAR PRADESH, India
Sharda Hospital Sharda University
🇮🇳Nagar, UTTAR PRADESH, India
Dr Manish Kumar Agarwal
Principal investigator
9838706199
dr.manishagarwal09@gmail.com