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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy; Elective Surgery
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75520
      • Civil Hospital Karachi
    • Karachi, Sindh, Pakistan, 75520
      • DUHS, Civil hospital Karachi (CHK)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dex Group; intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%	Drug: Dexmedetomidine; intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%; Other Names: Fentanyl
Experimental: Fent Group; intravenous fentanyl at 2mcg/kg in 100ml saline	Drug: Fentanyl; intravenous fentanyl at 2mcg/kg in 100ml saline; Other Names: Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	0 minute
Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	1 minute
Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	3 minute
Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	5 minute
Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	10 minute
Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	0 minute
Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minutes
Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 5 minutes
Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minutes
Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 0 minute
Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minutes
Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	5 minutes
Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minutes
Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 0 minute
Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minute
Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 5 minute
Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minute
SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 0 minute
SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minute
SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 5 minute
SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minute

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Sana Urooj, FCPS, Dr. Ruth K.M. Pfau Civil Hospital, Karachi

Publications and helpful links

General Publications

• Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 21, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Fentanyl; Dexmedetomidine; Intubation; Laparoscopic Cholecystectomy; Direct laryngoscopy; Hemodynamics response
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: SUrooj

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No