| CTRI Number |
CTRI/2018/05/013656 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
02/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparing two drugs i.e. Nalbuphine and Dexmedetomidine in attenuating intubation response ( increase in blood pressure and heart rate while inserting endotracheal tube) in patients for surgeries under general anaesthesia.
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Scientific Title of Study
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A comparative study of nalbuphine and dexmedetomidine on haemodynamic response to tracheal intubation in patients for surgeries under general anaesthesia
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| 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 |
Vishal Vashist |
| Designation |
Junior resident |
| Affiliation |
Dr.RPGMC Kangra at Tanda,HPU |
| Address |
Department of Anaesthesia, Dr. Rajendra Prasad Govt Medical College Kangra at Tanda, Himachal Prasad
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418115612 |
| Fax |
|
| Email |
vishalvashist1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudarshan Kumar |
| Designation |
Professor and Head |
| Affiliation |
Dr. RPGMC Kangra at Tanda,HPU |
| Address |
Department of Anaesthesia, Dr. Rajendra Prasad Govt Medical College Kangra at Tanda,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418086604 |
| Fax |
|
| Email |
sudarshan_58@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudarshan Kumar |
| Designation |
Professor and Head |
| Affiliation |
Dr. RPGMC Kangra at Tanda,HPU |
| Address |
Department of Anaesthesia, Dr. Rajendra Prasad Govt Medical College Kangra at Tanda,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418086604 |
| Fax |
|
| Email |
sudarshan_58@rediff.com |
|
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Source of Monetary or Material Support
|
| Principal Dr RPGMC Kangra at Tanda |
|
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Primary Sponsor
|
| Name |
Principal Dr RPGMC Kangra at Tanda |
| Address |
Department of Anaesthesia, Dr RPGMC kangra at Tanda, Himachal Prasad 176001
|
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishal Vashist |
Department of Anaesthesia |
SSB FLOOR 3, Dr. RPGMC,Tanda, Kangra
Kangra
HIMACHAL PRADESH |
9418115612
vishalvashist1986@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing elective surgery under general anaesthesia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous nalbuphine or dexmedetomidine drug before intubation |
to give the said drugs before intubation to prevent the intubation response and compare the two drugs |
| Comparator Agent |
to compare nalbuphine and dexmedetomidine for intubation response |
compare the two drugs to see effectiveness in preventing the intubation response |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patients undergoing elective surgeries under general anaesthesia.
2.Amercian society of Anesthesiologist physical status I-II.
3.BMI between 18.5-29.9 Kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Age <20yrs and >60yrs.
2. ASA grade 3 and 4.
3. History of allergy to any of study drugs.
4. Patients with peri-operative heart rate < 55bpm and/or Systolic BP < 90mmHg.
5. Patients receiving other alpha 2 agonists like clonidine or other opioid.
6.Patients noted to have dysrhythmias on the electrocardiogram (ECG).
7.Unwilling patients.
8.Patients who are opioid tolerant or opioid dependent.
9.Pregnant women.
10.Anticipated difficult intubation.
11.Patient with cardiac, pulmonary, neurologic, kidney diseases. |
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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 |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in HR and BP after laryngoscopy and intubation. |
Haemodynamic response every 1 min till 5 min and there onwards at 10 min,20 min,30 min |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To study and compare PONV and sedation score.
To observe for side effects of any of study drugs, if any. |
in interval of 2nd, 4th, 8th, 12th, 18th, 24th hour in post-operative period:
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/05/2018 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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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
|
The present study will be carried out on 60 patient, ASA I,aged between 20-60 yrs, scheduled for surgery under general anaesthesia.The patientwill be randomly divided into two groups. The allocated groups will be labelled as- Group D (n=30) receiving 1mcg/kg of dexmedetomidine in normal saline (total volume 20ml), Group N(n=30) receiving 0.2mg/kgof nalbuphine in normal saline (total volume 20 ml). The effect of nalbuphine and dexmedetomidine will be studied in two groups at intubation for the changes in haemodynamic parameters- pulse rate,systolic blood pressure,diastolic blood pressure,mean arterial pressure and oxygen saturation. Also sedation will be evaluated using Ramsay Sedation Score. The patients will also be closely monitored for any side effects in form of post operative nausea, vomiting and bradycardia. |