| CTRI Number |
CTRI/2016/01/006519 [Registered on: 14/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
13/01/2016 |
| 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 THREE DIFFERENT DOSES OF FENTANYL TO PREVENT HEMODYNAMIC STRESS RESPONSE DURING INTUBATION |
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Scientific Title of Study
|
“CLINICAL EVALUATION OF EFFICACY AND SAFETY OF THREE DIFFERENT DOSES OF FENTANYL TO PREVENT HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND INTUBATION: A RANDOMIZED DOUBLE BLIND CLINICAL STUDY†|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANOJ KUMAR |
| Designation |
RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR
Bhavnagar GUJARAT 380007 India |
| Phone |
7046482085 |
| Fax |
|
| Email |
DRMANOJRIMS@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
DR DCTRIPATHI |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR
Bhavnagar GUJARAT 380007 India |
| Phone |
9428408718 |
| Fax |
|
| Email |
drtripathi1961@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DR DCTRIPATHI |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR
GUJARAT 380007 India |
| Phone |
9428408718 |
| Fax |
|
| Email |
drtripathi1961@yahoo.co.in |
|
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Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE |
| Address |
GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR GUJARAT |
| Type of Sponsor |
Government medical college |
|
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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 |
| manoj kumar |
government medical college bhavnagar |
department of anaesthesia government medical college bhavnagar Bhavnagar GUJARAT |
7046482085
drmanojrims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD(HUMAN ETHICS COMMITTEE) |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
POSTED FOR ELECTIVE SURGERY, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj fentanyl |
2mcg/kg,3mcg/kg and 4mcg/kg of fentanyl intravenously as a sigle dose five minute before induction of anaesthesia. |
| Intervention |
inj.fentanyl |
2mcg/kg,3mcg/kg,and 4mcg/kg of fentanyl intravenously as a sigle dose five minute before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
• Age: 18 to 40 years.
• Gender: Either gender.
• Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
• Duration of surgery up to 2 hrs.
• ASA physical status I and II.
• BMI ≤ 25kg/m2.
• Informed written consent for participation in study.
|
|
| ExclusionCriteria |
| Details |
• Patients with diabetes, COPD, renal disease, cardiac diseases like IHD, hypertension, valvular heart disease, AV conduction block, aortic stenosis, left ventricular failure, etc.
• Patients on drugs having effects on heart rate and blood pressure (sedatives, opioids, β-blockers, calcium channel blockers, diuretics) and anti-psychiatric drugs.
• Pregnant women and lactating mothers.
• Anticipated difficult intubation.
• Intubation attempt lasting longer than 15 seconds.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the efficacy and safety of three different doses of fentanyl in attenuating haemodynamic stress response to laryngoscopy and endotracheal intubation. |
at baseline, 5minutes after fentanyl administration, at the time of intubation, and then at 1,3,5,10,15 and 20 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the sedative effect of fentanyl.
2. To observe complication if any, in three groups.
|
at baseline, 5minutes after fentanyl administration, at the time of intubation, and then at 1,3,5,10,15 and 20 minutes after intubation,intraoperative period,at the time of extubation and postoperative upto 120 minutes |
|
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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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/04/2015 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
To assess the efficacy and safety of three different doses of fentanyl in attenuating haemodynamic stress response to laryngoscopy and endotracheal intubation. To assess the sedative effect of fentanyl.To observe complication if any, in three groups. After approval from the institutional review board (IRB No. 504/2015) and informed written consent from patient, this prospective, randomized, double blind clinical study was carried out in 90 patients of either gender aged 18 to 40 years of ASA Physical status I and II scheduled for elective surgery under general anaesthesia requiring endotracheal intubation were enrolled in this study. After thorough preanaesthetic evaluation, patients with cardio respiratory diseases, diseases affecting autonomic system, taking medication affecting hemodynamic variables and sedation score, anticipated difficult intubation and Intubation attempt lasting longer than 15 seconds and antenatal females and body mass index more than 25 were excluded from study. Patients were fasted for 6 hours before surgery. In pre-anaesthetic preparation room monitoring for Heart Rate (HR), Non Invasive Blood Pressure (systolic, diastolic and mean arterial pressure) and peripheral oxygen saturation (SpO2), were established and baseline vital parameters were recorded.Patients were randomly divided into three groups 30 patients of each using computer generated random number sequence. Fentanyl in the doses of 2mcg/kg, 3mcg/kg and 4mcg/kg intravenously was given 5 minutes before induction of anaesthesia in group I, II and III respectively.All patients received a standard anaesthetic protocol. All the parameters selected (HR, SBP, DBP, MAP) were recorded at various specific timings-at baseline, 5minutes after fentanyl administration, at the time of intubation, and then at 1,3,5,10,15 and 20 minutes after intubation.At the end of surgery, neuromuscular blockade was reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg intravenously. After satisfying the extubation criteria, trachea was extubated and patients were transferred to post anaesthesia care unit. Sedation score was recorded at base line, 5 minutes after fentanyl injection, at the time of extubation, and then at 5,10,15,20,30,60,90 and 120 minutes after extubation in the postoperative period.
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