| CTRI Number |
CTRI/2021/07/034532 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
30/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dosage for dexmedetomidine in spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of 3 Different Dexmedetomidine Doses and Their Effect on the Duration of Spinal Anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashita Mowar |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Department of Anaesthesia, First Floor, OT complex, Bhojipura, Bareilly- Nainital Road, Bareilly
Bhojipura, Bareilly- Nainital Road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashita Mowar |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Department of Anaesthesia, First Floor, OT complex, Bhojipura, Bareilly- Nainital Road, Bareilly
Bhojipura, Bareilly- Nainital Road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashita Mowar |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Department of Anaesthesia, First Floor, OT complex, Bhojipura, Bareilly- Nainital Road, Bareilly
Bhojipura, Bareilly- Nainital Road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ram Murti Smarak Institute of Medical Sciences, Bhojipura, Bareilly-Nainital Road, Bareilly, Uttar Pradesh |
|
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Primary Sponsor
|
| Name |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Bhojipura, Bareilly-Nainital Road, Bareilly, Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashita Mowar Pahade |
Department of Anaesthesia, OT complex,first floor, SRMSIMS |
Bhojipura, Bareilly- Nainital Road
Bareilly
UTTAR PRADESH |
9568578724
drash.royals@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3 different doses (2.5microgram, 5 microgram, 10 microgram) will be compared amongst themselves. No control group |
Thirty patients per group were randomly allocated using sealed envelope technique into three groups namely Group A (Intrathecal (IT) bupivacaine 12.5 mg (2.5 ml) + Dexmedetomidine 2.5 mcg), Group B ( IT bupivacaine 12.5 mg (2.5 ml) + Dexmedetomidine 5 mcg and Group C ( IT bupivacaine 10 ug (2.5 ml) + Dexmedetomidine 10 mcg). |
| Intervention |
Intrathecal dexmedetomidine three different doses with hyperbaric Bupivacaine |
Thirty patients per group were randomly allocated using sealed envelope technique into three groups namely Group A (Intrathecal (IT) bupivacaine 12.5 mg (2.5 ml) + Dexmedetomidine 2.5 mcg), Group B ( IT bupivacaine 12.5 mg (2.5 ml) + Dexmedetomidine 5 mcg and Group C ( IT bupivacaine 10 ug (2.5 ml) + Dexmedetomidine 10 mcg). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Ninety patients belonging to ASA physical status I/II, aged 18-60 years of either sex, undergoing elective lower abdominal and lower limb surgeries under planned Subarachnoid Block (SAB). |
|
| ExclusionCriteria |
| Details |
Exclusion criteria included patient refusal, contraindication to SAB, hypersensitivity to the drugs being evaluated, Body Mass Index (BMI) more than 40 kg/m2, pregnancy, significant comorbid conditions like uncontrolled hypertension, congestive heart failure, myocardial infarction in the past 6 months, heart block, fixed cardiac output lesions. Cases that needed intraoperative conversion to general anesthesia were also excluded. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective was to ascertain a safe IT dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries and to analyze sensory and motor characteristics with drug combinations being evaluated by comparing duration of the spinal sensory blockade, onset of the sensory and motor blockade |
Onset of sensory blockade shall be defined as the time taken from the drug injection to the time to reach T10 level and the offset of sensory block shall be presumed when pin prick sensation at S1 dermatome has returned. Duration of sensory block will be defined as the time interval elapsed between onset of sensory block at T10 to regression of sensory block to S1. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome measures included level of sedation, comparison of hemodynamic variables and complications, if any. |
HR, NIBP(systolic , diastolic and mean NIBP) ,SpO2 will be monitored continuously during the course of surgery and data will be recorded at 5 minutes interval for first 20 minutes then at 15 minutes interval till end of first hour, then at 30 minutes interval for next one hour, hourly for further 2 hours, followed by 4 hourly till completion of 24 hrs |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2021 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study is based on old studies published in various research journals. no publication has been conducted on this topic by the investigators till date.
1. Shaikh SI, Dattatri R. Dexmedetomidine as an adjuvant to hyperbaric spinal bupivacaine for infra-umbilical procedures: A dose related study. Anaesth Pain Intensive Care 2014;18:180-5.
2. Koolwal P, Baj B, Madani K M, Somani M, Mathur V. Dose related prolongation of hyperbaric bupivacaine by dexmedetomidine in lower abdominal and limb surgeries requiring spinal anaesthesia " A randomized double blind controlled study. IOSR-JDMS [Internet]. 2015[ cited 14 May 2020]; 14(7) Ver VIII: 84-90. Available from http://www.iosrjournals.org/iosr-jdms/papers/Vol14-issue7/Version-8/S014788490.pdf |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drash.royals@gmail.com].
- For how long will this data be available start date provided 15-10-2021 and end date provided 26-08-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
BACKGROUND: Dexmedetomidine is increasingly being used in regional anesthesia as an adjuvant but there is no consensus on the optimum dose when used intrathecally. The study will be conducted to elucidate the dose-response relation between 3 different doses (2.5, 5, and 10 mcg) of Intrathecal dexmedetomidine as an adjuvant to hyperbaric 0.5% bupivacaine in patients undergoing elective lower abdominal and lower limb surgeries. METHODS: 90 Patients (18-60 years) will be randomized into 3 groups of 30 patients each to receive Intrathecal bupivacaine 12.5 mg (2.5 ml) with 2.5 mcg (group A), 5ug (group B), 10ug (group C) dexmedetomidine, respectively. Duration of the spinal sensory blockade (primary outcome), the onset of the blockade, time to rescue analgesia, level of sedation, duration of motor blockade, comparison of hemodynamic variables, and complications, if any, will be assessed. |