| CTRI Number |
CTRI/2023/05/052570 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of propofol and combination of propofol and phenylephrine for maintaining hemodynamics during general anaesthesia in neurosurgical patients |
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Scientific Title of Study
|
A comparative evaluation of the efficacy of propofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability during induction of general anaesthesia in neurosurgical patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rhea Thotungal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anaesthesiology
AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
85473616142 |
| Fax |
|
| Email |
rheathotungal137@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshutosh Kaushal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anaesthesiology
AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8765515521 |
| Fax |
|
| Email |
drashutosh.kaushal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rhea Thotungal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anaesthesiology
AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
85473616142 |
| Fax |
|
| Email |
rheathotungal137@gmail.com |
|
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Source of Monetary or Material Support
|
| AIIMS Bhopal,saketh nagar,madhya pradesh,462020 |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences,Bhopal |
| Address |
AIIMS Bhopal,saket nagar,462020
madhyapradesh |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rhea Thotungal |
AIIMS Bhopal Neurosurgery operation theatre |
3rd floor Modular Operation theatre,
Neurosurgery OT- 2,
AIIMS Bhopal
saket nagar,bhopal,madhyapradesh
462020
Bhopal
MADHYA PRADESH |
85473616142
rheathotungal137@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee-Student Research(IHEC-SR) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol(P) |
After obtaining baseline hemodynamic parameters, all patients will be administered intravenous fentanyl 2 mcg/Kg and midazolam 20 mcg/Kg.In group P, 5ml 0.9%NS will be added to 45ml of 1% propofol (10mg/ml of 1% propofol).The drug will be given in slow titrated doses till loss of response to verbal command, which will be considered as the end point of induction at this point BIS(Bispectral Index) will be documented.Inj. I.V Vecuronium 0.1 mg/Kg will be given after induction and I.V preservative free lignocaine 1.5 mg/Kg will be administered 3 minutes prior to anticipated direct laryngoscopy to suppress intubation response.Hypotension is defined as 20% decrease in blood pressure from the baseline value which will be treated with rescue bolus dose of 1 mcg/kg phenylephrine. If MAP increased 20% of the baseline value, then boluses of esmolol 0.5–1 mg/kg IV over 30 s will be given.PaCO2 will be maintained between 30 and 35 mmHg, and ventilation will be maintained with isoflurane (0.5-1 MAC), 50% oxygen and air. In both groups, study drug will be infused at rate of 50mcg/kg/min. Inj I.V fentanyl (1 mcg /kg/hr) and I.V vecuronium (0.1mg/kg) infusion will be started after induction and stop after skin closure.Hemodynamic parameters (HR, MAP, SBP, DBP), SPO2, and end‑tidal CO2 (EtCO2) will be recorded at baseline, just after induction, every 30 secs for 3 minutes after induction, just after intubation, then every 60 secs for 5 minutes after intubation, at head pin application, Burr hole, Craniotomy, Bone flap removal, Dural opening, Dural closure and Skin suture.Episodes of hypotension, hypertension and amount of vasopressors drugs if any will be documented |
| Intervention |
Propofol-phenylephrine(Group PP) |
After obtaining baseline hemodynamic parameters, all patients will be administered intravenous fentanyl 2 mcg/Kg and midazolam 20 mcg/Kg. In Group PP, 5ml of phenylephrine (100mcg/ml) will be added to 45ml of propofol (10mg/ml of 1% propofol). the respective drug will be given in slow titrated doses till loss of response to verbal command, which will be considered as the end point of induction and BIS(Bispectral index value) will be documented.Hypotension is defined as 20% decrease in blood pressure from the baseline value which will be treated with rescue bolus dose of 1 mcg/kg phenylephrine. If MAP increased 20% of the baseline value, then boluses of esmolol 0.5–1 mg/kg IV over 30 s will be given.The study drug will be infused at rate of 50mcg/kg/min. Inj I.V fentanyl (1 mcg /kg/hr) and I.V vecuronium (0.1mg/kg) infusion will be started after induction and stop after skin closure.Hemodynamic parameters (HR, MAP, SBP, DBP), SPO2, and end‑tidal CO2 (EtCO2) will be recorded at baseline, just after induction, every 30 secs for 3 minutes after induction, just after intubation, then every 60 secs for 5 minutes after intubation, at head pin application, Burr hole, Craniotomy, Bone flap removal, Dural opening, Dural closure and Skin suture.Episodes of hypotension, hypertension and amount of vasopressors drugs if any will be documented |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I - II patients scheduled for elective neurosurgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patients with known allergies to study drugs.
2.Patients with uncontrolled hypertension, coronary artery disease
3.Patients with anticipated difficult airway and patients who require more than 2 attempts or more than 30 sec for direct laryngoscopy
4.Patients with signs and symptoms of elevated ICP
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1.To measure and compare the mean arterial pressure (MAP), systolic blood pressure(SBP), diastolic blood pressure (DBP), and heart rate (HR) just after induction, every 30 secs for 3 minutes, just after intubation, then every 60 secs for 5 minutes
2. To measure the number of extra doses of intraoperative vasopressors required if any.
|
1.baseline
2.every 30sec after induction for 3min
3.60sec after intubation for 5min
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure and compare the mean arterial pressure (MAP), systolic blood pressure(SBP), diastolic blood pressure (DBP), and heart rate (HR) at head pin application, burr hole, craniotomy, bone flap removal, dural opening, dural closure and skin suture.
2. To measure the brain relaxation score intraoperatively between the two groups
|
1.at head pin application, burr hole, craniotomy, bone flap removal, dural opening, dural closure and skin suture.
2.brain relaxation score after dura opening |
|
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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)
|
30/05/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In neurosurgical patients, the goals of anaesthesia include the maintenance of adequate cerebral oxygenation, cerebral perfusion pressure (CPP), stable hemodynamics, brain relaxation and avoidance of techniques or agents that affect these factors.The haemodynamic stability is mainly important for most neurosurgical procedures, especially aneurysmal clipping, where maintaining a transmural pressure gradient is of utmost importance to prevent its rupture
Several agents, both inhalational and intravenous (IV), have been used for the induction and maintenance of anaesthesia in neurosurgery patients. Propofol is a very commonly used sedative agent which induces general anaesthesia by facilitation of inhibitory neurotransmission mediated by gamma�’aminobutyric acid.The hypotensive action of propofol has been linked to affect the cerebral perfusion pressure and hence many approaches have been used to mitigate the hypotensive episode.Phenylephrine has emerged as a promising vasopressor drug since its discovery in 1927 and is commonly used for mitigating the hypotension associated with propofol induction
Various studies using different concentrations of phenylephrine have been used in preventing hypotension in healthy adult patients, but we could not find any such study on neurosurgical patients where maintaining hemodynamics is very important.The hypothesis of this study is that combination of propofol and phenylephrine will provide a better intraoperative hemodynamic profile in neurosurgical patients compared to the standard propofol alone induction.
The aim of this study is to compare the efficacy of propofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability during induction in neurosurgical patients.
|