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

Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089592
• Other study ID #: SUrooj
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: September 2019
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystectomy
• Elective Surgery

Intervention

Drug:
• Dexmedetomidine
intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%
• Fentanyl
intravenous fentanyl at 2mcg/kg in 100ml saline

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Primary	Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	0 minute
Primary	Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	1 minute
Primary	Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	3 minute
Primary	Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	5 minute
Primary	Systolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	10 minute
Primary	Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Primary	Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	0 minute
Primary	Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Primary	Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minutes
Primary	Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 5 minutes
Primary	Diastolic blood pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minutes
Primary	Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Primary	Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 0 minute
Primary	Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Primary	Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minutes
Primary	Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	5 minutes
Primary	Heart rate	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minutes
Primary	Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Primary	Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 0 minute
Primary	Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Primary	Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minute
Primary	Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 5 minute
Primary	Mean atrial pressure	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minute
Primary	SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at Baseline
Primary	SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 0 minute
Primary	SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 1 minute
Primary	SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 3 minute
Primary	SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 5 minute
Primary	SpO (oxygen saturation)	Hemodynamic response(induction) will be assessed on different point in time during procedure	at 10 minute
Secondary	Ramsey score	Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response	at arrival
Secondary	Ramsey score	Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response	at 10 minutes
Secondary	Aldrete score	Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery	at arrival
Secondary	Aldrete score	Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery	at 10 min
Secondary	Complications	Post operative complication	Will be assessed within Hospital stay at follow for 1 week
Secondary	Laryngospasm	Post operative complication	Will be assessed within Hospital stay at follow for 1 week
Secondary	Bradycardia	Post operative complication	Will be assessed within Hospital stay at follow for 1 week
Secondary	Regurgitation	Post operative complication	Will be assessed within Hospital stay at follow for 1 week
Secondary	Post operative vomiting and nausea	Post operative complication	Will be assessed within Hospital stay at follow for 1 week
Secondary	Hypertension	Post operative complication	Will be assessed within Hospital stay at follow for 1 week
Secondary	Hypotension	Post operative complication	Will be assessed within Hospital stay at follow for 1 week