NCT04138472

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

October 14, 2019

Last Update Submit

February 6, 2020

Conditions

Laparoscopic Cholecystectomy

Keywords

DexmedetomidineFentanylLignocaineLaryngoscopyHemodynamic ResponseLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (5)

  • systolic blood pressure

    hermodynamic response (Top number will be assessed of blood pressure)

    at induction

  • Diastolic blood pressure

    hermodynamic response (bottom number will be assessed of blood pressure)

    at induction

  • mean atrial pressure

    Hemodynamic responses (average blood pressure in an individual during a single cardiac cycle)

    at induction

  • Heart rate

    Hemodynamic responses (average heart rate beats a minute)

    at induction

  • Oxygen saturation (SpO2)

    Hemodynamic responses) (arterial oxy-hemoglobin saturation is measured non-invasively by a finger pulse oximeter or handheld pulse oximeter,

    at induction

Secondary Outcomes (3)

  • Sedation assessment

    at 10 minutes post operative

  • Recovery assessment

    at 10 minutes post operatively

  • Complications

    1 week Post-operative(Operation -discharge)

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

Group A patients receive intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.

Drug: dexmedetomidine

Fentanyl

EXPERIMENTAL

Group B receives intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.

Drug: fentanyl

Lidocaine

EXPERIMENTAL

Group C patients receives intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.

Drug: lidocaine

Interventions

dexmedetomidineDRUG

intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.

Dexmedetomidine
fentanylDRUG

intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.

Fentanyl
lidocaineDRUG

intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.

Lidocaine

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 surgery
  • Intubation by skilled anesthetist of at least 2 years' experience
  • Intubation not more than 45 seconds

You may not qualify if:

  • Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction
  • Pregnant and lactating females
  • Short thick neck with anticipated difficult intubation
  • Any sort of obstructive restrictive or reactive airway disease
  • Patient allergic to any of the study medications.
  • Obese patients, Narcotic addicts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DUHS, Civil hospital Karachi (CHK)

Karachi, Sindh, 75520, Pakistan

RECRUITING

DUHS, Civil hospital Karachi (CHK)

Karachi, Sindh, 75520, Pakistan

RECRUITING

MeSH Terms

Interventions

DexmedetomidineFentanylLidocaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidinesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Sana Urooj, FCPS

CONTACT

+923333515690dr.sanaurooj@yahoo.com

Sana Urooj

CONTACT

03333515690dr.sanaurooj@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients do not know about the interventions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
SUrooj

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 24, 2019

Study Start

October 30, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)