Clinical trial NCT04089592: Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
Official title: Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy
Elective Surgery
Keywords: Laparoscopic Cholecystectomy
Dexmedetomidine
Fentanyl
Hemodynamics response
Direct laryngoscopy
Intubation
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT, Double-blind, Randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: at Baseline
measure: Systolic blood pressure
timeFrame: 0 minute
measure: Systolic blood pressure
timeFrame: 1 minute
measure: Systolic blood pressure
timeFrame: 3 minute
measure: Systolic blood pressure
timeFrame: 5 minute
measure: Systolic blood pressure
timeFrame: 10 minute
measure: Diastolic blood pressure
timeFrame: at Baseline
measure: Diastolic blood pressure
timeFrame: 0 minute
measure: Diastolic blood pressure
timeFrame: at 1 minute
measure: Diastolic blood pressure
timeFrame: at 3 minutes
measure: Diastolic blood pressure
timeFrame: at 5 minutes
measure: Diastolic blood pressure
timeFrame: at 10 minutes
measure: Heart rate
timeFrame: at Baseline
measure: Heart rate
timeFrame: at 0 minute
measure: Heart rate
timeFrame: at 1 minute
measure: Heart rate
timeFrame: at 3 minutes
measure: Heart rate
timeFrame: 5 minutes
measure: Heart rate
timeFrame: at 10 minutes
measure: Mean atrial pressure
timeFrame: at Baseline
measure: Mean atrial pressure
timeFrame: at 0 minute
measure: Mean atrial pressure
timeFrame: at 1 minute
measure: Mean atrial pressure
timeFrame: at 3 minute
measure: Mean atrial pressure
timeFrame: at 5 minute
measure: Mean atrial pressure
timeFrame: at 10 minute
measure: SpO (oxygen saturation)
timeFrame: at Baseline
measure: SpO (oxygen saturation)
timeFrame: at 0 minute
measure: SpO (oxygen saturation)
timeFrame: at 1 minute
measure: SpO (oxygen saturation)
timeFrame: at 3 minute
measure: SpO (oxygen saturation)
timeFrame: at 5 minute
measure: SpO (oxygen saturation)
timeFrame: at 10 minute
Secondary outcomes:
measure: Ramsey score
timeFrame: at arrival
measure: Ramsey score
timeFrame: at 10 minutes
measure: Aldrete score
timeFrame: at arrival
measure: Aldrete score
timeFrame: at 10 min
measure: Complications
timeFrame: Will be assessed within Hospital stay at follow for 1 week
measure: Laryngospasm
timeFrame: Will be assessed within Hospital stay at follow for 1 week
measure: Bradycardia
timeFrame: Will be assessed within Hospital stay at follow for 1 week
measure: Regurgitation
timeFrame: Will be assessed within Hospital stay at follow for 1 week
measure: Post operative vomiting and nausea
timeFrame: Will be assessed within Hospital stay at follow for 1 week
measure: Hypertension
timeFrame: Will be assessed within Hospital stay at follow for 1 week
measure: Hypotension
timeFrame: Will be assessed within Hospital stay at follow for 1 week
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil Hospital Karachi
state: Sindh
city: Karachi
country: Pakistan
facility: DUHS, Civil hospital Karachi (CHK)
state: Sindh
Study officials:
affiliation: Dr. Ruth K.M. Pfau Civil Hospital, Karachi
name: Sana Urooj, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.