| CTRI Number |
CTRI/2021/09/036111 [Registered on: 01/09/2021] Trial Registered Prospectively |
| Last Modified On: |
29/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of dexmedetomidine on eye and venous pressure in patients undergoing elective neurosurgical procedure. |
|
Scientific Title of Study
|
To evaluate the effect of dexmedetomidine as an anaesthetic adjuvant on optic nerve sheath diameter (ONSD) and central venous pressure (CVP) in patients undergoing elective neurosurgical procedures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karishma |
| Designation |
Junior resident |
| Affiliation |
Department of anesthesiology and critical care, Jawaharlal Nehru Medical hospital |
| Address |
Department of anesthesiology and critical care , Jawaharlal Nehru Medical college and hospital,AMU , Aligarh
Department of anesthesiology and critical care , Jawaharlal Nehru Medical College and hospital,AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8360348105 |
| Fax |
|
| Email |
karishmasinha1511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shahla Haleem |
| Designation |
Professor |
| Affiliation |
Department of anesthesiology and critical care , Jawaharlal Nehru Medical College and hospital |
| Address |
Department of anesthesiology and critical care, Jawaharlal Nehru Medical College and hospital,AMU , Aligarh
Department of anesthesiology and critical care, Jawaharlal Nehru Medical College and hospital,AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997448172 |
| Fax |
|
| Email |
shahlahaleem@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Karishma |
| Designation |
Junior resident |
| Affiliation |
Department of anesthesiology and critical care , Jawaharlal Nehru Medical College and hospital |
| Address |
Department of anesthesiology and critical care, Jawaharlal Nehru Medical College and hospital,AMU , Aligarh
Department of anesthesiology and critical care, Jawaharlal Nehru Medical College and hospital,AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8360348105 |
| Fax |
|
| Email |
karishmasinha1511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care,JNMCH,AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and critical care |
| Address |
JNMCH,Aligarh |
| Type of Sponsor |
Government 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 |
| Karishma |
JNMCH,AMU |
Department of anaesthesiology and critical care
Aligarh
UTTAR PRADESH |
8360348105
karishmasinha1511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine alone |
Dexmetedomidine IV bolus in a dose of 0.5 mcg/kg before start of anesthesia and continued as infusion in the dose of 0.2 mcg/ kg /hr until the start of skin closure, diluted in a 50 ml syringe. |
| Comparator Agent |
Placebo |
Placebo group shall be given 0.9 % normal saline IV bolus and infusion using 50 ml /hr in a manner similar and equivalent to the study group. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Written informed consent
ASA 1 and 2
Age - 15 - 60 years
Gender -male and female
Patients with elective neurosurgical procedures. |
|
| ExclusionCriteria |
| Details |
No extended intracranial pressure but increased optic nerve diameter.
Optic nerve disease such as optic neuritis , Arachnoid cyst of optic nerve.
Anterior orbital or cavernous sinus mass.
Known orbital injury or prior ocular surgery.
Histroy of allergy to alpha 2 agonists. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of dexmedetomidine as an anaesthetic adjuvant on optic nerve sheath diameter (ONSD) in adult patients.
To assess the effect of dexmedetomidine as an anaesthetic adjuvant on central venous pressure (CVP) in adult patients undergoing elective neurosurgical procedures. |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the correlation between ONSD and CVP in adult patients undergoing elective neurosurgical procedures.
Documentation of side effects -nausea , vomiting , hypotension, bradycardia,during and after surgery. |
10 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/09/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 - Anyone
- 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 [karishmasinha1511@gmail.com].
- For how long will this data be available start date provided 19-06-2021 and end date provided 19-06-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The goals of neuroanesthesia are to ensure stable peri operative cerebral hemodynamics and avoid sudden rise in intracranial pressure to prevent acute swelling. Rised intracranial pressure ice is usually morbidity, mortality, and poor neurological outcomes. Raised intracranial pressure can arise from intracranial SOL and nontraumatic origin. Monitoring of intracranial pressure therefore becomes necessary in patients Presenting with the space occupying lesions. Invasive intracranial pressure monitoring is gold standard but it is associated with complications. The use of bedside ocular ultrasonography in measuring optic nerve sheath diameter can be useful method for defecting raised intracranial pressure.It has the advantage of being a noninvasive,portable and easily preformed approach. Dexmedetomidine is a highly selective alpha -2 adrenoreceptor agonist recently introduced in anesthesia practice . It produces dose dependent sedation,anxiolytics and analgesia without respiratory depression. This study is therefore designed to evaluate the effect of Dexmedetomidine as an anesthetiser adjuvant on the size of optic nerve sheath diameter and central venous pressure in elective neurological procedures The goals of neuroanesthesia are to ensure stable peri operative cerebral hemodynamics and avoid sudden rise in intracranial pressure to prevent acute swelling. Rised intracranial pressure ice is usually morbidity, mortality, and poor neurological outcomes. Raised intracranial pressure can arise from intracranial SOL and nontraumatic origin. Monitoring of intracranial pressure therefore becomes necessary in patients Presenting with the space occupying lesions. Invasive intracranial pressure monitoring is gold standard but it is associated with complications. The use of bedside ocular ultrasonography in measuring optic nerve sheath diameter can be useful method for defecting raised intracranial pressure.It has the advantage of being a noninvasive,portable and easily preformed approach. Dexmedetomidine is a highly selective alpha -2 adrenoreceptor agonist recently introduced in anesthesia practice . It produces dose dependent sedation,anxiolytics and analgesia without respiratory depression. This study is therefore designed to evaluate the effect of Dexmedetomidine as an anesthetiser adjuvant on the size of optic nerve sheath diameter and central venous pressure in elective neurological procedures. |