CTRI

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CTRI Number

CTRI/2025/10/096005 [Registered on: 13/10/2025] Trial Registered Prospectively

Last Modified On:

13/10/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A comparison of two drugs effect (Dexmedetomidine versus Magnesium sulphate) on postoperative delirium in patients undergoing head and neck oncological surgeries

Scientific Title of Study

A comparative study on the effect of Dexmedetomidine versus Magnesium sulphate on postoperative delirium in the patients undergoing head and neck oncological surgeries- A prospective randomized 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 Bhagyashree
Designation	Senior Resident
Affiliation	AIIMS, Bhopal
Address	Department of Anesthesia and Critical Care 3rd Floor All India Institute of Medical Sciences Saket Nagar Bhopal Bhopal MADHYA PRADESH 462020 India
Phone	9731420882
Fax
Email	bhagyashree90.bg@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Harish Kumar
Designation	Associate Professor
Affiliation	AIIMS, Bhopal
Address	Department of Anesthesia and Critical Care 3rd Floor All India Institute of Medical Sciences Saket Nagar Bhopal Bhopal MADHYA PRADESH 462020 India
Phone	9471300943
Fax
Email	harish.anesth@aiimsbhopal.edu

Details of Contact Person
Public Query

Name	Dr Harish Kumar
Designation	Associate Professor
Affiliation	AIIMS, Bhopal
Address	Department of Anesthesia and Critical Care 3rd Floor All India Institute of Medical Sciences Saket Nagar Bhopal Bhopal MADHYA PRADESH 462020 India
Phone	9471300943
Fax
Email	harish.anesth@aiimsbhopal.edu

Source of Monetary or Material Support

AIIMS, Bhopal Madhya Pradesh

Primary Sponsor

Name	All India Institute of Medical Sciences, Bhopal
Address	Department of Anesthesia and Critical care 3rd Floor All India Institute Of Medical Sciences Saket Nagar Bhopal-462020 Madhya Pradesh
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Bhagyashree	AIIMS, Bhopal	Modular OT Complex Department of Anaesthesia and critical care Department of Surgical Oncology Department of ENT AIIMS Campus Saket Nagar Bhopal MADHYA PRADESH	9731420882 bhagyashree90.bg@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethics Committee- Student Research (IHEC-SR), AIIMS Bhopal	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Dexmedtomidine	Intravenous loading dose with 1mcg/kg over 10 minutes and infusion 0.5mcg/kg till the end of surgery
Comparator Agent	Magnesium Sulphate	Intravenous 30 mg/kg over 10 minutes followed by infusion of 10 mg/kg till the end of the surgery

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	ASA physical status I and II Planned for head and neck oncological surgery

ExclusionCriteria

Details

Patient with psychological disorder
Patient with history of stroke or cognitive dysfunction
Patient with inability to communicate (coma, language barrier, deaf )
Chronic or acute intake of sedative or anticonvulsant drug
Patients with severe cardiac dysfunction, renal or hepatic dysfunction
Bradycardia (Heart rate less than 50 bpm)
Allergy to study drugs
Surgical duration more than 6 hours

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To assess postoperative delirium using CAM-ICU score in patients undergoing head and neck surgeries in dexmedetomidine and magnesium sulphate group	Postoperative day 2(T1) Postoperative day 5 (T5)

Secondary Outcome

Outcome	TimePoints
To monitor effects of dexmedetomidine and magnesium sulphate on heart rate and BP Introperatively	Baseline(T0) Post loading dose (T1) Intraoperative period every hourly
To record total dose of intraoperative fentanyl used to evaluate opioid -sparing effect of each agent	At the end of surgery
To assess the sleep quality using Richard Campbell Sleep Questionnaire	Postoperative day 2 Post operative day 5

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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)

27/10/2025

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="1"
Months="6"
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

Postoperative delirium is acute fluctuating course in attention with disturbance in attention and cognition which leads to increase in hospital stay and increased morbidity is crippling complication of the head and neck oncological surgery. To ameliorate this complications both pharmacological and non-pharmacological measures have been used. Drugs like dexmedetomidine, ketamine, dexamethasone, magnesium sulphate have been proposed to decrease the occurrence of delirium and emergence agitation. Informed consent will be taken by the principal investigator from all the patients fulfilling inclusion criteria by explaining the details of the study in their own language in presence of a witness. A computer generated randomization of the selected patients according to the inclusion criteria and group will be assigned. Preoperatively, Mental status will be assessed using Mini Cog a day prior to the surgery. Preoperative orders will be given as per institutional protocol and patients will be advised to skip the benzodiazepines a night before the surgery. On the day of surgery patient will be shifted to operation theatre and after noting the baseline haemodynamic parameters, patient will be intubated as required for the head and neck surgery. After the induction the patient will be given the drug as the allocated group.

Group D – Dexmedetomidine infusion-0.5 mcg/kg loading dose over 10 minutes followed by 0.5 mcg/kg/hour intravenously

Group M – Magnesium sulphate infusion- 30 mg/kg loading dose over 10 minutes followed by10 mg/kg/hour intravenously

Intraoperatively haemodynamic parameters will be noted after the loading dose of infusion and thereafter every hourly. Rescue fentanyl (1 mcg/kg) will be administered if heart rate and blood pressure increased to more than 20%. Analgesia will be maintained with paracetamol 1gm and additional dose of opioids or analgesics as required.

Patient will be shifted to ICU for postoperative mechanical ventilation and patient will be sedated with intravenous fentanyl. Patient will be extubated on postoperative day 1 after fulfulling the extubation crtieria. CAM-ICU score and sleep quality will be assesed using Richard campbell Questionnaire on postoperative day 2 and 5. Patient will be discharged as the surgical team.