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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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