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

Sponsor

Dow University of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04089592

Collaborator

(none)

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholecystectomy Elective Surgery	Drug: Dexmedetomidine Drug: Fentanyl	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RCT, Double-blind, Randomized control trialRCT, Double-blind, Randomized control trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Patient meeting the inclusion criteria will be randomly allocated divided into two groups by chit paper method A, B (30 participants in each group).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

May 15, 2019

Actual Study Completion Date :

Jul 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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