To access the effects of two group of drug combination on hemp dynamic changes during tracheal intubation

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/058692
• Lead Sponsor: non

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-10
• Study Start: 2023-12-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patient with the history of difficult intubation 2.
• Patient with anticipated difficult airway 3.
• Patients having history of endocrine, cardiovascular, renal or CNS disease.
• Patient having BMI > 30 kg m-2 5.
• Patient on anti-hypertensive or narcotic drugs.

Exclusion Criteria

• Patient with the history of difficult intubation 2.
• Patient with anticipated difficult airway 3.
• Patients having history of endocrine, cardiovascular, renal or CNS disease.
• Patient having BMI > 30 kg m-2 5.
• Patient on anti-hypertensive or narcotic drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. To compare the diastolic & mean blood pressure following laryngoscopy & intubation between two groups	2. To compare post-operative pain by VAS score

Trial Locations

Locations (1)

School of medical science and research,Sharda University; 🇮🇳 Nagar, UTTAR PRADESH, India

School of medical science and research,Sharda University

🇮🇳Nagar, UTTAR PRADESH, India

DR Mahendra Kumar

Principal investigator

9868399709

mahendramohit@gmail.com