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

NCT04089592 | Completed

• 1 other identifier: SUrooj
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cholecystectomy; Elective Surgery

Keywords

Laparoscopic Cholecystectomy; Dexmedetomidine; Fentanyl; Hemodynamics response; Direct laryngoscopy; Intubation

Outcome Measures

Primary Outcomes (30)

• 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 Outcomes (11)

• Ramsey score

  at arrival

• Ramsey score

  at 10 minutes

• Aldrete score

  at arrival

• Aldrete score

  at 10 min

• Complications

  Will be assessed within Hospital stay at follow for 1 week

Study Arms (2)

Dex Group

EXPERIMENTAL

intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%

Drug: Dexmedetomidine

Fent Group

EXPERIMENTAL

intravenous fentanyl at 2mcg/kg in 100ml saline

Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%

Also known as: Fentanyl

Dex Group

Fentanyl DRUG

intravenous fentanyl at 2mcg/kg in 100ml saline

Also known as: Dexmedetomidine

Fent Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (2)

Civil Hospital Karachi

Karachi, Sindh, 75520, Pakistan

Location

DUHS, Civil hospital Karachi (CHK)

Karachi, Sindh, 75520, Pakistan

Location

Related 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/2017/27020.10578. Epub 2017 Sep 1.

  PMID: 29207810 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Sana Urooj, FCPS

  Dr. Ruth K.M. Pfau Civil Hospital, Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patient meeting the inclusion criteria will be randomly allocated divided into two groups by chit paper method A, B (30 participants in each group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: RCT, Double-blind, Randomized control trial

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 13, 2019
• Study Start: January 15, 2019
• Primary Completion: May 15, 2019
• Study Completion: July 15, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)