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

September 21, 2019 updated by: Sana Urooj, Dow University of Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
at Baseline
Systolic blood pressure
Time Frame: 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
0 minute
Systolic blood pressure
Time Frame: 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
1 minute
Systolic blood pressure
Time Frame: 3 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
3 minute
Systolic blood pressure
Time Frame: 5 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
5 minute
Systolic blood pressure
Time Frame: 10 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
10 minute
Diastolic blood pressure
Time Frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
at Baseline
Diastolic blood pressure
Time Frame: 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
0 minute
Diastolic blood pressure
Time Frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 1 minute
Diastolic blood pressure
Time Frame: at 3 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 3 minutes
Diastolic blood pressure
Time Frame: at 5 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 5 minutes
Diastolic blood pressure
Time Frame: at 10 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 10 minutes
Heart rate
Time Frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
at Baseline
Heart rate
Time Frame: at 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 0 minute
Heart rate
Time Frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 1 minute
Heart rate
Time Frame: at 3 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 3 minutes
Heart rate
Time Frame: 5 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
5 minutes
Heart rate
Time Frame: at 10 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 10 minutes
Mean atrial pressure
Time Frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
at Baseline
Mean atrial pressure
Time Frame: at 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 0 minute
Mean atrial pressure
Time Frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 1 minute
Mean atrial pressure
Time Frame: at 3 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 3 minute
Mean atrial pressure
Time Frame: at 5 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 5 minute
Mean atrial pressure
Time Frame: at 10 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 10 minute
SpO (oxygen saturation)
Time Frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
at Baseline
SpO (oxygen saturation)
Time Frame: at 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 0 minute
SpO (oxygen saturation)
Time Frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 1 minute
SpO (oxygen saturation)
Time Frame: at 3 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 3 minute
SpO (oxygen saturation)
Time Frame: at 5 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 5 minute
SpO (oxygen saturation)
Time Frame: at 10 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
at 10 minute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ramsey score
Time Frame: at arrival
Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response
at arrival
Ramsey score
Time Frame: at 10 minutes
Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response
at 10 minutes
Aldrete score
Time Frame: at arrival
Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery
at arrival
Aldrete score
Time Frame: at 10 min
Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery
at 10 min
Complications
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week
Laryngospasm
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week
Bradycardia
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week
Regurgitation
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week
Post operative vomiting and nausea
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week
Hypertension
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week
Hypotension
Time Frame: Will be assessed within Hospital stay at follow for 1 week
Post operative complication
Will be assessed within Hospital stay at follow for 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sana Urooj, FCPS, Dr. Ruth K.M. Pfau Civil Hospital, Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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