| CTRI Number |
CTRI/2025/08/092888 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Intravenous Drugs to Prevent Surges in Blood pressure and Heart Rate During Skull Pin Placement in Brain Tumor Surgery. |
|
Scientific Title of Study
|
Intravenous Dexmedetomidine (1mcg/kg) versus Intravenous Magnesium Sulphate (50mg/kg)for attenuation of the Hemodynamic Stress Response During Skull Pin Insertion in Patients with Intracranial Neoplasms Undergoing Elective Craniotomy: A Prospective Randomized Comparative Study. |
| 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 Arjun Raveendran |
| Designation |
DNB Resident |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences |
| Address |
Department of Anesthesia
Sri Sathya Sai Institute of Higher Medical Sciences
EPIP Area, Whitefield
Bengaluru
Bangalore
KARNATAKA
560066
India |
| Phone |
8921731765 |
| Fax |
|
| Email |
arjunravi0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vrushali Choudhary |
| Designation |
Additional Senior Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences |
| Address |
Department of Anesthesia
Sri Sathya Sai Institute of Higher Medical Sciences
EPIP Area, Whitefield
Bengaluru
Bangalore
KARNATAKA
560066
India |
| Phone |
8308836873 |
| Fax |
|
| Email |
choudhary.vrushali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Anitha Diwakar |
| Designation |
Senior Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences |
| Address |
Department of Anesthesia
Sri Sathya Sai Institute of Higher Medical Sciences
EPIP Area, Whitefield
Bengaluru
Bangalore
KARNATAKA
560066
India |
| Phone |
8861681405 |
| Fax |
|
| Email |
anitha.d@sssihms.org.in |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Higher Medical Sciences,
EPIP Area, Whitefield, Bengaluru, India 560066 |
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Medical Sciences |
| Address |
Sri Sathya Sai Institute of Higher Medical Sciences, EPIP Area, Whitefield, Bengaluru, India 560066 |
| Type of Sponsor |
Other [Trust 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 |
| Dr Arjun Raveendran |
Sri Sathya Sai Institute of Higher Medical Sciences |
F1201, First floor
Sri Sathya Sai Institute of Higher Medical Sciences
EPIP Area, Whitefield
Bengaluru 560066
Bangalore
KARNATAKA |
08921731765
arjunravi0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Sathya Sai Institute of Higher Medical Sciences, Whitefield. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Dexmedetomidine
1 mcg/kg |
Intravenous Dexmedetomidine
1 mcg/kg will be administered before pin insertion and hemodynamic parameters will be monitored |
| Intervention |
Intravenous Magnesium Sulphate 50 mg/kg |
Intravenous Magnesium Sulphate 50 mg/kg will be administered before pin insertion and hemodynamic parameters will be monitored. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA II aged between 18 to 60 years with intracranial neoplasms undergoing elective craniotomy. |
|
| ExclusionCriteria |
| Details |
Patients with known history of allergy to the study drugs.
Patients in hypovolemia, heart blocks etc.
Patients undergoing emergency surgeries.
Patients with more than 20% drop in hemodynamic parameters after study drug administration
•Patients with hypermagnesemia.
|
|
|
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 |
1.Measure and compare heart rate between two groups.
2.Measure and compare systolic blood pressure, diastolic blood pressure and mean arterial pressure between two groups. |
Before induction, five minutes after intubation, before pin insertion, at the time of pin insertion, one minute, five minutes, 10 minutes, 20 minutes, 30 minutes after pin insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the total fentanyl requirement up to 30 minutes post pin insertion between two groups.
2. Compare the incidence of adverse effects related to study drugs in both groups. |
Up to 30 minutes post pin insertion. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/08/2025 |
| 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="8"
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 randomized controlled trial aims to compare efficacy of
intravenous dexmedetomidine and intravenous magnesium sulphate in attenuating
the hemodynamic response to scalp pin insertion in patients with intracranial
neoplasms undergoing elective craniotomy procedures. The study will include
patients aged 18 to 60 years with an ASA physical status ii. A total of 60
patients will be randomly allocated in to two groups
Group D: intravenous dexmedetomidine 1 mcg/kg
Group M: intravenous magnesium sulphate 50 mg/kg
Each group consist of 30 patients. Study drugs will be
administered according to the assigned group.
Heart rate, systolic, diastolic and mean arterial pressures
will be recorded at the following time points,
Pre induction,5 minutes after intubation, before and during
pin insertion, 1 minute, 5 minutes, 10 minutes, 20minutes, 30 minutes following
pin placement. These measurements will be taken by an anaesthesiologist who is
blinded to the patients group allocation and total fentanyl requirement up to
30 minutes will also will be recorded. Magnesium level monitored in all
patients pre operatively and after study drug administration
Statistical analysis: data will be entered in to Microsoft
excel data sheet and will be analysed using IBM SPSS version 22 software (Armonk,
Ny: IBM Corp) software. Normal distribution of data will be assessed with the Kolmogorov
Smirnov test. Categorical data will be represented in the form of frequencies
and proportions. Chi square test will be the test of significance. Continuous
data will be represented as mean and standard deviation. Independent t test
will the test of significance to identify the mean proportion between two
groups. The Mann Whitney U test will used for the non-normality distributed
data. P value <0.05 will be considered as statistically significant.
|