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

Not Applicable

Completed

• Conditions: Cholecystectomy; Elective Surgery
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT04089592
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy.

Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients.

Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no research work available at the national level and scarcity of data at an international level with inconclusive outcomes. Our participation in the form of this research will add to scientific literature and step up ahead at the international level.

Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic value is analgesia and sedation. It is extensively used for anesthetic and analgesic most often in operating room and ICU.

Detailed Description

This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery.

Study Timeline

• Study Start: 2019-01-15
• Primary Completion: 2019-05-15
• Study Completion: 2019-07-15
• Study First Submitted: 2019-08-22
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Last Update Submitted: 2019-09-21
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. ASA-I and ll patients
2. Male and female patient of age 20-70 years.
3. Undergoing Elective laparoscopic cholecystectomy.

Exclusion Criteria

1. Pregnant and lactating females
2. Short thick neck with anticipated difficult intubation.
3. Obese patients.
4. Narcotic addicts.
5. Full stomach patient or with higher chances of aspiration.
6. Patient allergic to any of the study medications.
7. Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dex Group	Dexmedetomidine	intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%
Fent Group	Fentanyl	intravenous fentanyl at 2mcg/kg in 100ml saline

Primary Outcome Measures

Name	Time	Method
Heart rate	at 10 minutes	Hemodynamic response(induction) will be assessed on different point in time during procedure
Systolic blood pressure	10 minute	Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure	at 10 minutes	Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure	at 10 minute	Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)	at 10 minute	Hemodynamic response(induction) will be assessed on different point in time during procedure

Secondary Outcome Measures

Name	Time	Method
Complications	Will be assessed within Hospital stay at follow for 1 week	Post operative complication
Hypertension	Will be assessed within Hospital stay at follow for 1 week	Post operative complication
Ramsey score	at 10 minutes	Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response
Post operative vomiting and nausea	Will be assessed within Hospital stay at follow for 1 week	Post operative complication
Hypotension	Will be assessed within Hospital stay at follow for 1 week	Post operative complication
Laryngospasm	Will be assessed within Hospital stay at follow for 1 week	Post operative complication
Bradycardia	Will be assessed within Hospital stay at follow for 1 week	Post operative complication
Aldrete score	at 10 min	Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery
Regurgitation	Will be assessed within Hospital stay at follow for 1 week	Post operative complication

Trial Locations

Locations (2)

Civil Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan

DUHS, Civil hospital Karachi (CHK); 🇵🇰 Karachi, Sindh, Pakistan