CTRI Number |
CTRI/2023/09/057760 [Registered on: 18/09/2023] Trial Registered Prospectively |
Last Modified On: |
16/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
The study the effect of intranasal and intravenous dexmeditomidine |
Scientific Title of Study
|
Comparative study of intranasal and intravenous dexmeditomidine for attenuation of haemodynamic responses to laryngoscopy and endotracheal intubation in adult surgical patients under general anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr. Himanshu Gautam |
Designation |
PG Resident |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 |
Address |
Room no-05, Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029
South West DELHI 110029 India |
Phone |
9717312007 |
Fax |
|
Email |
HIMANSHUGAUTAM9441@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Rajpal Singh |
Designation |
Professor and Consultant |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 |
Address |
Room no-05, Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029
South West DELHI 110029 India |
Phone |
9811858311 |
Fax |
|
Email |
doctorrajpal04@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr. Rajpal Singh |
Designation |
Professor and Consultant |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 |
Address |
Room no-05, Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029
South West DELHI 110078 India |
Phone |
9717312007 |
Fax |
|
Email |
himanshugautam9441@gmail.com |
|
Source of Monetary or Material Support
|
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 |
|
Primary Sponsor
|
Name |
Vardhman Mahavir Medical College New Delhi |
Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 |
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 |
Dr Himanshu Gautam |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 South West DELHI |
9717312007
himanshugautam9441@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 |
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 |
Comparator Agent |
Intranasal 0.9% normal saline |
Administration of intranasal 0.9% normal saline drops for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. |
Intervention |
Intranasal dexmeditomidine |
Administration of intranasal dexmeditomidine for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. |
Comparator Agent |
Intravenous 0.9% normal saline |
Administration of 0.9% normal saline for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. |
Intervention |
Intravenous Dexmeditomidine |
Administration of intravenous dexmeditomidine for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Adult patients belonging to ASA grade I &II
2.Scheduled for elecytive surgery under general anaestheia. |
|
ExclusionCriteria |
Details |
1. Uncooperating, non consenting patients.
2. Known allery or hypersenstivity to dexmeditomidine.
3. Pregnant, lactating mothers, Cardiac or respratory disease, uncontrolled hypertension, diabetes mellitus type II, neurological or psychiatric disease, or any intranasal pathology{like nasal ulcers, polyps, nasaal septal deviation}. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mean arterial pressure{MAP} |
40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Systolic blood pressure{SBP}, diastolic blood pressure{DBP} & heart rate. |
40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 3/ Phase 4 |
Date of First Enrollment (India)
|
25/09/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
METHODOLOGY All patients satisfying inclusion criteria will undergo detailed preanaesthetic evaluation. After explaining the nature of the study, an informed consent will be obtained from all patients willing to participate in the study, followed by a complete physical examination. 100 adults, will be included in this study. All patients will be randomly allocated to one of study groups using computer generated randomization. The patients will be then divided into two groups Group -A(Intravenous dexmeditoidine) and Group B(Intranasal dexmeditomidine). All patients of both groups will be advised for fasting of 6 hours and premedication of tablet ranitidine (150 mg) and alprazolam (0.5 mg) on the night before surgery.
On the day of operation, all patients will be shifted to preoperative room 2 h before the operation time. Monitoring like electrocardiography (ECG), plethysmography (SPO2), non- invasive blood pressure (NIB) monitoring will be attached and baseline readings will be obtained. Intravenous access(18G) will be secured and IV Ringer’s lactate solution will be administered as maintenance fluid. The study drug will be prepared and given by some senior anaesthesiologist and monitoring of parameters will be done by different anaesthesiologist. Group A(Dexmeditomidine intravenous) will be given IV DEXMEDITOMIDINE (0.50 ug/kg) diluted in 40 ml of normal saline (NS) through an infusion pump over 40 min and I ml of NS intranasal will be instilled in equal volume in both nostrils before induction at the same time. Group B(Dexmeditomidine intranasal) will be instilled Im| DEXMEDITOMIDINE in both nostrils in equal volume and 40ml of normal saline (NS) intravenously through an infusion pump over 40 min before induction. All the patients of both groups will be advised not to sneeze or suck after intranasal drug administration.
Then after completion of study drug administration, patient will be shifted in the operation room, standardised monitoring like electrocardiography (ECG), plethysmography (SP02). noninvasive blood pressure (NIBP), End tidal carbondioxide (EtCO2) monitoring will be connected and before induction readings will be noted.
All patients will be pre- oxygenated with 100% oxygen for 3 minutes. Fentanyl citrate 2 meg/kg, and titrated dose of Propofol 1-2 mg/kg will be given over 45second till the loss of consciousness . After ensuring check ventilation , vecuronium bromide 0.1 mg/kg body weight will be administered intravenously. Patient will be ventilated with mixture of oxygen + NO(50:50) and Isoflurane (MAC- 1) for 4 min and then endotracheal intubation with appropriate cuffed endotracheal tube will be performed. After confirming for bilateral equal airentry, the endo-tracheal tube will be fixed and normocapnic ventilation will be started with monitoring of ECG, HR, NIBP/IBP, EtCO2 and SpOz Readings at 2,5,7and 9 minutes after intubation will be noted Maintenance of anaesthesia will be continued with 02 + NO(40:60) and Isoflurane (MAC-1) All haemodynamic parameters will be monitored continuously and any adverse events like bradycardia, tachycardia, hypertension, hypotension or arrhythmia will be recorded and appropriate management will be done. Additional doses of neuromuscular blockade i.e. inj. vecuronium bromide 0.025mg/kg as and when required and analgesic inj. fentanyl 1meg/kg one and hourly would be given according to duration of surgery. Inj Ondansetron 4mg intravenous will be given 30 min before end of surgery. After completion of surgery, neuromuscular block will be reversed by appropriate dose of IV neostigmine (0.05 mg/kg) and glycopyrolate (0.01 mg/kg).
After adequate muscle power recovery patient will be extubated and will be shifted to the recovery room after stabilization Patents vitals will be monitored there for 2 h and when Modified Alderate score ›9, the patient will be shifted to ward. |