Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04138472
• Other study ID #: 3
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: February 2020
• Source: Dow University of Health Sciences
• Contact: Sana Urooj, FCPS
• Phone: +923333515690
• Email: dr.sanaurooj[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Description:

Direct laryngoscopy and intubation are painful stimulus that activates sympathoadrenal discharge which results in intense cardiovascular reflex i.e. tachycardia and hypertension. In this study we will compare effects of intravenous dexmedetomidine, fentanyl and lidocaine for attenuation of these reflexes in patient undergoing laproscopic cholecystectomy. how these agents will effect hemodynamic response during pneumoperitoneum. Tertiary objective will be to observe sedation, perioperative complications and recovery in these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA-I and ll patients

• Male and female patient of age 20-70 years.

• Undergoing Elective surgery

• Intubation by skilled anesthetist of at least 2 years' experience

• Intubation not more than 45 seconds

Exclusion Criteria:

• Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction

• Pregnant and lactating females

• Short thick neck with anticipated difficult intubation

• Any sort of obstructive restrictive or reactive airway disease

• Patient allergic to any of the study medications.

• Obese patients, Narcotic addicts

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• dexmedetomidine
intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.
• fentanyl
intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.
• lidocaine
intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.

Locations

Country	Name	City	State
Pakistan	DUHS, Civil hospital Karachi (CHK)	Karachi	Sindh
Pakistan	DUHS, Civil hospital Karachi (CHK)	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Sana Urooj	Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure	hermodynamic response (Top number will be assessed of blood pressure)	at induction
Primary	Diastolic blood pressure	hermodynamic response (bottom number will be assessed of blood pressure)	at induction
Primary	mean atrial pressure	Hemodynamic responses (average blood pressure in an individual during a single cardiac cycle)	at induction
Primary	Heart rate	Hemodynamic responses (average heart rate beats a minute)	at induction
Primary	Oxygen saturation (SpO2)	Hemodynamic responses) (arterial oxy-hemoglobin saturation is measured non-invasively by a finger pulse oximeter or handheld pulse oximeter,	at induction
Secondary	Sedation assessment	Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response	at 10 minutes post operative
Secondary	Recovery assessment	Aldret score use for recovery assessment, it consist of 0-10 point where 0 indicates worst(no response) and 10 indicates good response	at 10 minutes post operatively
Secondary	Complications	Cough, Laryngospasm, Bradycardia, Regugitation, PONV, Hypertention, Hypotension	1 week Post-operative(Operation -discharge)