CTRI

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CTRI Number

CTRI/2025/08/093458 [Registered on: 22/08/2025] Trial Registered Prospectively

Last Modified On:

21/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Evaluating Various Doses of Dexmedetomidine with Spinal Anaesthesia for Lower Limb Surgeries

Scientific Title of Study

COMPARISON OF DIFFERENT DOSES OF DEXMEDETOMIDINE AS ADJUVANT TO HYPERBARIC BUPIVACAINE IN SPINAL ANAESTHESIA FOR LOWER LIMB ORTHOPAEDIC SURGERIES

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Lalit kumar
Designation	DNB JR
Affiliation	Government Multi Speciality Hospital- 16, CHANDIGARH
Address	Anaesthesia Department,Government Multi Speciality Hospital-Sector16 CHANDIGARH Chandigarh CHANDIGARH 160023 India
Phone	08427899953
Fax
Email	lalitbishnoi72@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sabhayata Sharma
Designation	SMO and Guide
Affiliation	Government Multi Speciality Hospital - 16, CHANDIGARH
Address	Anaesthesia Department,Government Multi Speciality Hospital-Sector16 CHANDIGARH Chandigarh CHANDIGARH 160023 India
Phone	09814683689
Fax
Email	sanjeevsabhayata@gmail.com

Details of Contact Person
Public Query

Name	Dr Vineet Kaur
Designation	SMO and Co guide
Affiliation	Government Multi Speciality Hospital - 16, CHANDIGARH
Address	Anaesthesia Department,Government Multi Speciality Hospital-Sector16 CHANDIGARH Chandigarh CHANDIGARH 160016 India
Phone	09876797338
Fax
Email	kaurvineet1973@gmail.com

Source of Monetary or Material Support

nil

Primary Sponsor

Name	Government Multi Speciality Hospital
Address	Sector 16 A , Chandigarh Pincode -160023
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
government multispeciality hospital	sector 16 A, chandigarh

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Lalit kumar	Government Multi Speciality Hospital	Department of Anaesthesia, 1st floor ,ICU complex, Sector- 16 A , Chandigarh Chandigarh CHANDIGARH	08427899953 lalitbishnoi72@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
The Institutional Ethics Committee (IEC) of Government Multi-Speciality Hospital	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
Intervention	dexmedetomidine	group I will receive 3.0 ml of 0.5 percentage heavy bupivacaine (15 mg) with 0.5 ml of dexmedetomidine (5microgram) intrathecally. Group II will recieve 3.0 ml of 0.5 percent of heavy bupivacaine (15 mg) with 0.3 ml of dexmedetomidine (3 microgram) with 0.2 ml of sterile normal saline intrathecally. Duration of surgery less than 2.5 hour.
Comparator Agent	Normal saline	Group III will receive 3.0 ml of 0.5 percent heavy bupivacaine (15 mg) with 0.5 ml of sterile normal saline intrathecally. Duration of surgery less than 2.5 hour total volume of the drug injected will be kept the same that is 3.5 ml in all the three groups.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1)Age group 18 to 60 years 2)ASA physical status grade I and grade II 3)Weight 50 to 90 kg 4)Height 150 to 180 cm 5)Patients giving consent for the study

ExclusionCriteria

Details

1)Patients with any contraindication to regional anaesthesia
2)Patients with a history of significant co existing diseases like uncontrolled diabetes ,
uncontrolled hypertension, ischaemic heart disease, recent myocardial infarction, heart
block, impaired renal functions and severe liver disease.
3)Patients with spine deformities like Kyphoscoliosis, Scoliosis etc.
4)Patient with a history of allergy to the drugs to be used.
5)Patient on alpha2 agonist or antagonist therapy.
6)Expected duration of surgery more than 2.5 hours

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Double Blind Double Dummy

Primary Outcome

Outcome	TimePoints
To determine duration of analgesia	12 Hours

Secondary Outcome

Outcome	TimePoints
1)To determine the onset and duration of sensory and motor blockade 2)To study the effect on haemodynamic parameters. 3)To study side effects, if any.	12 Hours

Target Sample Size

Total Sample Size="99"
Sample Size from India="99"
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 3/ Phase 4

Date of First Enrollment (India)

01/09/2025

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="1"
Months="0"
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

this is prospective double blind randomised controlled study. In patients, undergoing lower limb surgeries under spinal anaesthesia with hyperbaric bupivacaine, the study will compare the effect of adding two different doses of dexmedetomidine(3 microgram and 5 microgram) to hyperbaric bupivacaine in spinal anaesthesia for lower limb orthopaedic surgeries at government multispeciality hospital ,sec 16A ,chandigarh.