| CTRI Number |
CTRI/2021/07/034887 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
BIS index guided comparison of Dexmedetomidine and Fentanyl premedication for time required to achieve adequate depth for endotracheal intubation– Randomised Control Trial |
|
Scientific Title of Study
|
Bispectral index guided comparison of Dexmedetomidine and Fentanyl premedication for time required to achieve adequate depth for endotracheal intubation– A Prospective Double Blind Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Faseehullah Alam |
| Designation |
Senior Resident |
| Affiliation |
IGIMS |
| Address |
Department of Anesthesiology, IGIMS, Sheikpura ,Patna
Patna
BIHAR
800014
India |
| Phone |
9155366231 |
| Fax |
|
| Email |
faseehullah.alam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Faseehullah Alam |
| Designation |
Senior Resident |
| Affiliation |
IGIMS |
| Address |
Department of Anesthesiology, IGIMS, Sheikpura ,Patna
Department of Anesthesiology, IGIMS, Sheikpura ,Patna
BIHAR
800014
India |
| Phone |
9155366231 |
| Fax |
|
| Email |
faseehullah.alam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Faseehullah Alam |
| Designation |
Senior Resident |
| Affiliation |
IGIMS |
| Address |
Department of Anesthesiology, IGIMS, Sheikpura ,Patna
Patna
BIHAR
800014
India |
| Phone |
9155366231 |
| Fax |
|
| Email |
faseehullah.alam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mohammad Faseehullah Alam , IGIMS ,PATNA |
|
|
Primary Sponsor
|
| Name |
Mohammad Faseehullah Alam |
| Address |
Department of Anesthesiology, IGIMS, Sheikpura ,Patna |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Mohammad Faseehullah Alam |
IGIMS |
Department of Anesthesiology, IGIMS, Sheikpura ,Patna
Patna
BIHAR |
9155366231
faseehullah.alam@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 3||Administration, (3) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To assess the time required to achieve adequate BIS for endotracheal intubation after patients receive dexmedetomidine (1µg/kg) in 100 ml normal saline |
patients will be kept npo 6 hours for solid food, and 2 hours for clear liquids before surgery. Premedication will be injected glycopyrrolate 10 mcg/kg intramuscularly. After taking the patient in the operating room all necessary attachments like ECG electrodes, NIBP monitors, SPo2 probes, BIS monitors will be attached. After securing the IV cannula patient will receive the study drug , infusion Dexmedetomidine (1µg/kg) in 100 ml Normal saline over 10 minutes . After 15 minutes induction will be done with Inj. Propofol 2mg/kg and Cis-atracurium 0.15mg/kg. Intubation will be attempted in 3 minutes if desired BIS is achieved. Maximum waiting period will be for 6 minutes, after that rescue drug injection propofol in 1mg/kg will be repeated. Intubation will be attempted only at BIS ≤50. |
| Comparator Agent |
To assess the time required to achieve adequate BIS for endotracheal intubation after patients receive fenatnyl (2µg/kg) in 100 ml normal saline. |
patients will be kept nil per orally 6 hours for solid food, and 2 hours for clear liquids before surgery. Premedication will be injected glycopyrrolate 10 mcg/kg intramuscularly. After taking the patient in the operating room all necessary attachments like ECG electrodes, NIBP monitors, SPo2 probes, BIS monitors will be attached. After securing the IV cannula patient will receive the study drug Infusion Fentanyl (2µg/kg) in 100 ml Normal saline over 10 minutes.
After 15 minutes induction will be done with Inj. Propofol 2mg/kg and Cis-atracurium 0.15mg/kg. Intubation will be attempted in 3 minutes if desired BIS is achieved. Maximum waiting period will be for 6 minutes, after that rescue drug injection propofol in 1mg/kg will be repeated. Intubation will be attempted only at BIS ≤50. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18 to 50 years of both sex undergoing elective surgery under general anaesthesia.
2)ASA 1 and 2.
3)Consenting patients. |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)ASA 3 & 4
3) History of Allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the time required to achieve adequate BIS for endotracheal intubation. |
3 minutes if desired BIS is achieved. Maximum waiting period will be for 6 minutes, after that rescue drug injection propofol in 1mg/kg will be repeated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare haemodynamic between both the groups.
Total amount of rescue drug required to achieve the desired BIS. |
3 minutes if desired BIS is achieved. Maximum waiting period will be for 6 minutes, after that rescue drug injection propofol in 1mg/kg will be repeated. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Choudhary, Annu; Singh, Swati; Singh, Swati; Alam, Faseehullah1; Kumar, Harsh. Bispectral index-guided comparison of dexmedetomidine and fentanyl as an adjuvant with propofol to achieve an adequate depth for endotracheal intubation - A double-blind randomised controlled trial. Indian Journal of Anaesthesia 68(4):p 334-339, April 2024. | DOI: 10.4103/ija.ija_884_23 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The BIS monitor, derived from electroencephalogram (EEG) data, has been used as a statistical predictor of the level of hypnosis and has been proposed as a tool to reduce the risk of intraoperative awareness. Bispectral index (BIS) is a widely used quantitative parameter for evaluating depth of anesthesia and sedation. Fentanyl and dexmedetomidine has potent sedative properties. They have been used as an anesthetic sparing agent but not as a sole anesthetic agent as premedication. In view of above facts, this study aims to assess the time required to achieve adequate depth for intubation, using Bispectral index as guide. |