CTRI Number |
CTRI/2018/03/012744 [Registered on: 22/03/2018] Trial Registered Retrospectively |
Last Modified On: |
14/03/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Effect of addition of different drugs before layngoscopy and intubation to prevent rise in BP and heart rate in patients undergoing general anaesthesia |
Scientific Title of Study
|
A study to compare the Pressor Responses to Laryngoscopy and Endotracheal Intubation with intravenous Dexmedetomidine vs Magnesium sulphate as premedicants in surgical patients under BIS monitored 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 Ruchi Gupta |
Designation |
Professor and Head, Department of Anaesthesia, SGRDIMSR |
Affiliation |
SGRDIMSR |
Address |
Department of anaesthesia and critical care,
Sri Guru Ram Das Institute of Medical Sciences and Research,
Vallah,
Sri Amritsar
Punjab
143501
India
Amritsar PUNJAB 143501 India |
Phone |
9814320805 |
Fax |
|
Email |
drruchisgrd@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manjot Kaur |
Designation |
Junior Resident |
Affiliation |
SGRDIMSR |
Address |
Department of anaesthesia and critical care,
Sri Guru Ram Das Institute of Medical Sciences and Research,
Vallah,
Sri Amritsar
Punjab
143501
India
Department of anaesthesia and critical care,
Sri Guru Ram Das Institute of Medical Sciences and Research,
Vallah,
Sri Amritsar
Punjab
143501
India
Amritsar PUNJAB 143501 India |
Phone |
9478706278 |
Fax |
|
Email |
manjotkaur1417@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kuljit Singh Aujla |
Designation |
Professor |
Affiliation |
SGRDIMSR |
Address |
Department of anaesthesia and critical care,
Sri Guru Ram Das Institute of Medical Sciences and Research,
Vallah,
Sri Amritsar
Punjab
143501
India
Amritsar PUNJAB 143501 India |
Phone |
9814420438 |
Fax |
|
Email |
drkuljitsinghaujla@gmail.com |
|
Source of Monetary or Material Support
|
Sri Guru Ram Das Institute of Medical Sciences and Research,
Vallah,
Amritsar,
Punjab |
|
Primary Sponsor
|
Name |
SGRDIMSR |
Address |
Sri Guru Ram Das Institute of Medical Sciences & Research,
Vallah,
Amritsar,
Punjab |
Type of Sponsor |
Private 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 Ruchi Gupta |
SGRDIMSR, Amritsar |
Operation Theatre Complex,
First Floor, Wing B
Department Of Anaesthesia Amritsar PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
General Surgery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intravenous premedication with dexmedetomidine and magnesium suphate |
To study blunting of pressor response under BIS monitoring |
Comparator Agent |
Slow intravenous injection of 1 ug/kg dexmedetomidine and 30 mg/kg magnesium sulphate in 100 ml normal saline as adjuvants 15-20 minutes prior to induction of general anaesthesia |
To evaluate the changes in heart rate, blood pressure, mean arterial pressure and ECG in response to laryngoscopy & intubation before study drug, after study drug, at induction every 1 minute till 5 minutes, then every 2 minutes till 10 minutes and every 10 minutes thereafter in patients undergoing elective surgery under BIS monitored general anaesthesia. To study & compare the effect on heart rate, blood pressure, mean arterial pressure and ECG of i.v. dexmedetomidine 1µg/kg and i.v. magnesium sulphate 30 mg/kg. To evaluate incidence of side effects & perioperative complications.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA physical status I and II
Scheduled for elective surgery under GA
|
|
ExclusionCriteria |
Details |
1. ASA III and above
2. Major hepatic, renal or cardiovascular dysfunction
3. Pregnancy, PIH
4. Patients on anticoagulation therapy
5. Postural hypotension
6. Anticipated difficult airway
7. Uncontrolled hypertension and myocardial disease
8. Surgeries involving anticipated major blood losses and fluid shifts
9. Patients on sedatives other than used for study
10. Patients with drug allergies
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Attenuation haemodynamic stress response to laryngoscopy and intubation |
15 minutes after study drug infusion till 30 minutes post-intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Propofol and muscle relaxant sparing effect of dexmedetomidine and magnesium sulphate, respectively |
15 minutes after study drug infusion till whole of intraoperative period |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
30/01/2016 |
Date of Study Completion (India) |
24/08/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
After taking an approval from hospital ethics committee and a written
informed consent, 120 patients in the age group of 18-60 years of either sex,
ASA grade I and II were allocated into three groups of 40 patients each in a
randomized double blind manner with every patient receiving 100 ml of test drug
solution via intravenous route as follows: Group I (n=40):
Dexmedetomidine 1 µg/kg in normal saline making a total of 100ml Group II (n=40):
Magnesium sulphate 30mg/kg in normal saline making a total of 100ml Group III (n=40):
Normal saline to a total of 100ml The
results were compiled and compared statistically in terms of demographics,
duration of surgery, sedation scores, BIS values, hemodynamic parameters-
heart rate, systolic blood pressure, diastolic blood pressure, mean arterial
pressure and ECG changes and any adverse
effects. All the groups were comparable in terms of age, sex and ASA status. Dose
of propofol required for intubation and the dose of vecuronium required
intraoperatively were also recorded. To summarize- 1. Lower BIS levels themselves facilitated
smooth tracheal intubation without any pressor responses as seen in placebo
group. 2. Use of both dexmedetomidine and
magnesium sulphate may prove beneficial in the
anaesthesia settings where BIS monitoring facilities are lacking, due to their BP
& HR lowering properties. 3. However,
both the adjuvants i.e. dexmedetomidine and magnesium sulphate reduced the time
to reach BIS 40-60 by producing sedative effects, but
Ramsay Sedation Scores were comparatively higher in dexmedetomidine group. 4. Sparing
of propofol was exceptionally more in dexmedetomidine treated study population. 5. MgSO4 although caused less
propofol sparing effect but had an additional vecuronium sparing effect. 6. In balanced anaesthesia, titration of propofol and
other anaesthetic agents guided by BIS index, decreases the incidence of intraoperative awareness, decreases the
dose of propofol and significantly improves the recovery.
7. Use of BIS monitoring as an objective marker for
assessing the level of consciousness and as a guide
to determine end points of anaesthetic requirements, can prevent the over-infusion or under-dosage of anesthetic drugs.
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