CTRI

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CTRI Number

CTRI/2025/01/079224 [Registered on: 22/01/2025] Trial Registered Prospectively

Last Modified On:

21/01/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Study of effects in the presence and absence of intravenous dexmedetomidine on sensory block after spinal anesthesia with 0.5 percent hyperbaric bupivacaine in patients undergoing lower limb surgeries.

Scientific Title of Study

A Randomized Controlled Study To Evaluate The Effects With Or Without Intravenous Dexmedetomidine As A Pre Medication On Sensory Block Induced By Spinal Anesthesia With 0.5 Percent Hyperbaric Bupivacaine In Lower Limb Surgeries SMS Medical College Jaipur

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Shriphal Meena
Designation	Senior Professor
Affiliation	Sawai Man Singh Medical College
Address	Department Of Anaesthesiology Dhanwantri OPD Block SMS Medical College Jaipur Rajasthan Jaipur RAJASTHAN 302004 India
Phone	9928350391
Fax
Email	dr.shriphal@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shriphal Meena
Designation	Senior Professor
Affiliation	Sawai Man Singh Medical College
Address	Department Of Anaesthesiology Dhanwantri OPD Block SMS Medical College Jaipur Rajasthan Jaipur RAJASTHAN 302004 India
Phone	9928350391
Fax
Email	dr.shriphal@gmail.com

Details of Contact Person
Public Query

Name	Dr Aakshi
Designation	PG Resident
Affiliation	SMS Medical College
Address	Department of Anaesthesiology Dhanwantri OPD Block SMS Medical College Jaipur Rajasthan Jaipur RAJASTHAN 302004 India
Phone	8544892534
Fax
Email	aakshibharadwaj1995@gmail.com

Source of Monetary or Material Support

Department Of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 India

Primary Sponsor

Name	Department Of Anaesthesia Sawai Man Singh Medical College and Attached Hoapital Jaipur
Address	Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shriphal Meena	Sawai Man Singh Medical College and Attached Hospital Jaipur	Department of Anesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 Jaipur RAJASTHAN	9928350391 dr.shriphal@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Intravenous Dexmedetomidine	To evaluate the effects with or without intravenous dexmedetomidine 1 mcg per kg bodyweight in 10ml 0.9% normal saline as a pre medication on sensory block induced by spinal anesthesia with 15mg 0.5% hyperbaric bupivacaine in patients undergoing lower limb surgeries.Route of Administration- Intravenous.Duration of intervention -Single injection
Intervention	Spinal anesthesia in lower limb surgeries	To evaluate the effects with or without intravenous dexmedetomidine 1 mcg per kg bodyweight in 10ml 0.9% normal saline as a pre medication on sensory block induced by spinal anesthesia with 15mg 0.5% hyperbaric bupivacaine in patients undergoing lower limb surgeries.Route of Administration- Intravenous.Duration of intervention-Single injection.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1.Written Informed Consent 2.Age group of 18 to 50 years 3.Both genders 4.Patients of ASA Grade I and II 5.Weight of Patient 50 to 90 kg 6.Patients undergoing lower limb surgeries 7.Height of Patient more than 150 cm

ExclusionCriteria

Details

1.Patient with history of drug allergy to local anaesthestics
2.Patient with coagulation disorders or taking anticoagulant drugs
3.Patient on alpha 2 agonists and beta blockers
4.Patient with history of heart blocks ,heart rate less than 50 per minute and dysrhytmias
5.Patient with uncontrolled metabolic disease
6.Psychologically unstable patients with preexisting neurological deficits
7.Patient with Spinal Deformities
8.Patient not included in any other study

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Mean onset and duration of sensory blockade	1.0 min 2.2 min 3.4 min 4.6 min 5.8 min 6.10 min 7.25 min 8.40 min 9.55 min

Secondary Outcome

Outcome	TimePoints
Mean onset of motor blockade(minutes) Mean duration of motor blockade(minutes) Mean level of Sedation Mean of HR,SBP,DBP,MAP,SP02 Mean time for first rescue analgesia Proportion of cases with side effects / complications	1.0 min 2.2 min 3.4 min 4.6 min 5.8 min 6.10 min 7.15 min 8.20 min 9.25 min 10.30 min 11.35 min 12.40 min 13.45 min 14.50 min 15.55 min 16.60 min

Target Sample Size

Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)

10/02/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Spinal anesthesia is a type of regional anesthesia which is commonly used technique for lower abdominal , lower limb surgeries. Spinal anesthesia with bupivacaine is the most preferred technique of anesthesia . Bupivacaine when used in recommended doses, under spinal anesthesia produces complete sensory and motor blockade. Various adjuvants like dexmedetomidine , opioids are added to enhance the effects of the local anesthetics .Dexmedetomidine potentiates the anesthetic effects of all intraoperative anesthetics, regardless of method of administration .Recent studies show that dexmedetomidine prolongs the sensory blockade induced by spinal anesthesia .

For this a total of 66 patients(n=66) undergoing lower limb surgeries will be randomly divided into two groups(Group A and Group B).Group A patients will receive 10 ml 0.9% normal saline as infusion over 10 minutes ,20 minutes prior to subarachnoid block with 15 mg 0.5% hyperbaric bupivacaine and Group B patients will receive 1mcg/kg body weight dexmedetomidine in 10 ml 0.9% normal saline as infusion over 10 minutes, 20 minutes prior to subarachnoid block.

Patient will be received in operation theatre , intravenous cannula will be secured and hemodynamic variables will be noted .Loading dose of intravenous dexmedetomidine and normal saline as per study group will be given.

Surgery will be started after T10 level sensory blockade is achieved. Quantitative values of time of onset and duration of sensory and motor blockade ,time taken for sensory regression and request of first rescue analgesia will be recorded.