CTRI Number |
CTRI/2023/10/058692 [Registered on: 16/10/2023] Trial Registered Prospectively |
Last Modified On: |
10/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
To access the effects of two group of drug combination on hemp dynamic changes during tracheal intubation
|
Scientific Title of Study
|
Comparison of effects of Fentanyl and Lidocaine versus Nalbuphine and Lidocaine on haemodynamic responses to laryngoscopy and intubation
|
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Hadiya Ajaz |
Designation |
Post graduate resident |
Affiliation |
School of medical science and research, Sharda university |
Address |
Department of Anesthesia, B division room no 2
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9596000400 |
Fax |
|
Email |
Chowdharyaijaz@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Mahendra Kumar |
Designation |
Professor |
Affiliation |
School of medical science and research, Sharda university |
Address |
Department of Anesthesia, B division room no 2
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9868399709 |
Fax |
|
Email |
Mahendramohit@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Mahendra Kumar |
Designation |
Professor |
Affiliation |
School of medical science and research, Sharda university |
Address |
Department of Anesthesia, B division room no 2
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9868399709 |
Fax |
|
Email |
Mahendramohit@yahoo.com |
|
Source of Monetary or Material Support
|
School of medical science and research,Sharda University |
|
Primary Sponsor
|
Name |
non |
Address |
non |
Type of Sponsor |
Other [non] |
|
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 Mahendra Kumar |
School of medical science and research,Sharda University |
Department of anesthesia , B division , room no 2 .Plot No. 32, SHARDA UNIVERSITY Campus, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201306 Gautam Buddha Nagar UTTAR PRADESH |
9868399709
mahendramohit@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee |
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 |
Intervention |
Fentanyl |
2mcg/Kg of fentany diluted to 5 ml with normal saline , given intravenously immediately followed by injection lidocaine1.5mg/kg intravenouslydiluted to normal saline iv
|
Comparator Agent |
nalbuphine |
inj nalbuphine 0.2mcg/kg diluted to 5 ml with normal saline immediately followed by inl lidocaine 1.5mg/kg diluted to 5ml with normal saline intravenously |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patient with the history of difficult intubation
2. Patient with anticipated difficult airway
3. Patients having history of endocrine, cardiovascular, renal or CNS disease.
4. Patient having BMI > 30 kg m-2
5. Patient on anti-hypertensive or narcotic drugs |
|
ExclusionCriteria |
Details |
1. Patient with the history of difficult intubation
2. Patient with anticipated difficult airway
3. Patients having history of endocrine, cardiovascular, renal or CNS disease.
4. Patient having BMI > 30 kg m-2
5. Patient on anti-hypertensive or narcotic drugs |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To compare the heart rate & systolic blood pressure of two groups following laryngoscopy & intubation. |
i. Preoperative (baseline values) i.e. before injection of study drug
ii. Before induction of anaesthesia (after injection of study drug)
iii. After induction of anaesthesia i.e. just before laryngoscopy & intubation
iv. Post intubation at 0min, 1 min, 2 min, 3min, 5min, 7min, 10min and 15min
v. Then every 15 min till the end of surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To compare the diastolic & mean blood pressure following laryngoscopy & intubation between two groups
2. To compare post-operative pain by VAS score
3. To compare post-operative sedation score
​ |
Post intubation at 0min, 1 min, 2 min, 3min, 5min, 7min, 10min & 15min
v. Then every 15 min till the end of surgery
1. Haemodynamic parameters (HR, SBP, DBP, MAP, SpO2) will be recorded at 0 min, then every 15 minutes for 1 hour and then every hour for next 2 hours post operatively.
2. Following post-operative parameters will be recorded at 0, 1, 2, & 3 hrs
i) Pain (VAS) score
ii) Sedation score
|
|
Target Sample Size
|
Total Sample Size="21" Sample Size from India="21"
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)
|
12/12/2023 |
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
|
Laryngoscopy and endotracheal intubation are one of the most necessary steps in general anaesthesia. Both laryngoscopy and intubation produce sympathetic stimulation and cause release of catecholamines leading to increase in heart rate and blood pressure which are classified as pressor response.1 In a healthy patient these changes are well tolerable but in patients having cardiovascular comorbidities, raised intracranial pressure and cerebral vascular anomalies, these haemodynamic changes may be detrimental. Pressor responses after intubation have been associated with cerebral haemorrhage, ventricular arrhythmias, ST-segment abnormalities, pulmonary oedema. These changes are associated with rise in catecholamine levels.2 For non-anaesthetic applications, laryngoscopy and tracheal intubations are also used to maintain airway. Diagnostic direct laryngoscopy and fibreoptic bronchoscopy are frequently utilised. All these methods have the potential to elicit sympathetic responses. A majority of these patients are either critically ill or at increased risk. This arises concern to attenuate these haemodynamic changes in response to laryngoscopy and intubation. In past years, various drugs have been used to attenuate the haemodynamic responses to laryngoscopy and intubation like calcium channel blocker3, opioids4-9, magnesium sulphate10, vasodilators11, lignocaine7-9, alpha 2 agonists12 etc. but no ideal agent has been found till date. Opioids in particular have been reported to be helpful in reducing these cardiovascular responses. Fentanyl, a synthetic pure μ-receptor agonist and Nalbuphine, a semi-synthetic opioid agonist–antagonist analgesic have been used widely to attenuate the pressor response following laryngoscopy and intubation.4-9 But in few studies it has been reported that Nalbuphine has poor response in this regard as compared to Fentanyl.5,6 Lignocaine has also been used intravenously for attenuating these stress responses by its direct myocardial depressant effect, central stimulant effect, and peripheral vasodilatory effect and it also suppresses the cough reflex, an effect on synaptic transmission.13 Lignocaine is one of the cheapest and safest drugs used widely to attenuate stress response to laryngoscopy and intubation.7-9 Fentanyl along with Lidocaine has shown same effect on pressure response to laryngoscopy and intubation as shown by fentanyl alone.7,8 As nalbuphine has shown poor control on haemodynamic responses to laryngoscopy and intubation as compared to fentanyl, hence it is proposed to assess the haemodynamic effects of fentanyl and lidocaine and compared with the haemodynamic effects of nalbuphine and lidocaine following laryngoscopy and intubation. Extensive search of literature did not show any study comparing the effects of fentanyl with lidocaine and nalbuphine with lidocaine on haemodynamic responses to laryngoscopy and intubation. Therefore, in the present study, effects of fentanyl with lidocaine and nalbuphine with lidocaine on haemodynamic responses to laryngoscopy and intubation will be assessed and compared. |