| CTRI Number |
CTRI/2013/11/004174 [Registered on: 28/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A trial to study whether dexmedetomidine, a new anaesthetic drug added to local anaesthetic ropivacaine for blocking nerves supplying upper limb improves the quality of anaesthesia. |
|
Scientific Title of Study
|
To evaluate the effect of dexmedetomidine added to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset time, duration of sensory, motor block and analgesia. |
| 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 Indira Gurajala |
| Designation |
Assistant Professor, Department of Anaesthesiology and Critical Care, |
| Affiliation |
Nizams Institute of Medical Sciences, Hyderabad. |
| Address |
1-9-485/2, Lalithanagar,Jamai Osmania, Hyderabad.
Hyderabad
ANDHRA PRADESH
500044
India |
| Phone |
07729932044 |
| Fax |
091-40-23310076 |
| Email |
indiradevraj@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Assistant Professor, Department of Anaesthesiology and Critical Care, |
| Affiliation |
Nizams Institute of Medical Sciences, Hyderabad. |
| Address |
1-9-485/2, Lalithanagar,Jamai Osmania, Hyderabad.
Hyderabad
ANDHRA PRADESH
500044
India |
| Phone |
07729932044 |
| Fax |
091-40-23310076 |
| Email |
indiradevraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Assistant Professor, Department of Anaesthesiology and Critical Care, |
| Affiliation |
Nizams Institute of Medical Sciences, Hyderabad. |
| Address |
1-9-485/2, Lalithanagar,Jamai Osmania, Hyderabad.
Hyderabad
ANDHRA PRADESH
500044
India |
| Phone |
07729932044 |
| Fax |
091-40-23310076 |
| Email |
indiradevraj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Institution –Nizams Institute of Medical Sciences, Hyderabad |
|
|
Primary Sponsor
|
| Name |
NIZAMS INSTITUTE OF MEDICAL SCIENCES HYDERABAD |
| Address |
Nizams Institute of Medical Sciences, Hyderabad.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrIndira Gurajala |
orthopaedic operation theatre, Main operation theatre complex and postoperative ward no 9 |
Nizams Institute Of Medical Sciences, Hyderabad.
Hyderabad
ANDHRA PRADESH |
07729932044
091-40-23310076
indiradevraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In patients undergoing upper limb orthopedic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
dexmedetomidine ,50 micrograms(0.5 ml) added to 35 ml of 0.5% ropivacaine will be injected once around the nerves (brachial plexus)supplying the upper limb |
| Comparator Agent |
saline |
0.5 ml of saline (placebo) is added to 35 ml of 0.5% ropivacaine for injection once around the nerves(brachial plexus) supplying the upper limb |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
• Patients undergoing upperlimb orthopedic surgery under supraclavicular brachial plexus block and general anaesthesia.
• Age more than 18 years.
• ASA physical status 1&2
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
• Patients receiving adrenoreceptor agonist or antagonist therapy;
• those with a history of cardiac, respiratory, hepatic,or renal failure;
• patients with head injury and known psychiatric disordes
• and pregnant women were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of dexmedetomidine added to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset time, duration of sensory, motor block and analgesia. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective is to evaluate whether dexmedetomidine added to 0.5% ropivacaine for supraclavicular brachial plexus block reduces the requirements of general anaesthetics. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/08/2013 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
The trial CTRI/2013/11/004174 is complete. The study titled "To evaluate the effect of dexmedetomidine added to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset time, duration of analgesia, sensory block and motor block and its interaction with general anaesthesia." has been accepted for publication in Indian Journal of Anaesthesia.
Thanking You
Yours sincerely
Indira Gurajala
|
|
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
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [indiradevraj@yahoo.co.in].
- For how long will this data be available start date provided 01-05-2015 and end date provided 01-02-2020?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Background and aims: The effect of perineural dexmedetomidine on the time to onset, quality and duration of motor block with ropivacaine has been equivocal and its interaction with general anaesthesia (GA) has not been reported. We assessed the influence of dexmedetomidine added to 0.5% ropivacaine on the characteristics of supraclavicular brachial plexus block and its interaction with GA. Methods: In a randomised, double blind study, 36 patients scheduled for orthopaedic surgery on the upper limb under supraclavicular block and GA were divided into either R group (35 ml of 0.5% ropivacaine with 0.5 ml of normal saline [n - 18]) or RD group (35 mL of 0.5% ropivacaine with 50 μg dexmedetomidine [n - 18]). The onset time and duration of motor and sensory blockade were noted. The requirement of general anaesthetics was recorded. Results: Both the groups were comparable in demographic characteristics. The time of onset of sensory block was not significantly different. The proportion of patients who achieved complete motor blockade was more in the RD group. The onset of motor block was earlier in group RD than group R (P < 0.05). The durations of analgesia, sensory and motor blockade were significantly prolonged in group RD (P < 0.00). The requirement of entropy guided anaesthetic agents was not different in both groups. Conclusions: The addition of dexmedetomidine to 0.5% ropivacaine improved the time of onset, quality and duration of supraclavicular brachial plexus block but did not decrease the requirement of anaesthetic agents during GA. Keywords: Dexmedetomidine; brachial plexus block; requirement of general anaesthetics. |
|