Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

NCT04646317 | Unknown Early Phase 1 DMC

• 1 other identifier: PfauCHKarachi
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy.

Conditions

Hypertension; Laparoscopic Cholecystectomy

Keywords

Attenuation; dexmedetomidine; pneumoperitoneum; hemodynamic stability; pressor response; laryngoscopy response; intubation response

Outcome Measures

Primary Outcomes (4)

• Change in Systolic blood pressure during pneumoperitoneum

  Systolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

  From baseline to the end of pneumoperitonium, an average of 2 hours

• change in Diastolic blood pressure during pneumoperitoneum

  Diastolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

  from baseline to the end of pneumoperitoneum, an average of 2 hours

• change in Mean Arterial blood pressure during pneumoperitoneum

  Mean Arterial blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

  from baseline to the end of pneumoperitoneum, an average of 2 hours

• change in Heart Rate during pneumoperitoneum

  Heart rate will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

  from baseline to the end of pneumoperitoneum, an average of 2 hours

Secondary Outcomes (7)

• Systolic blood pressure intubation

  Induction

• Diastolic Blood pressure intubation

  Induction

• Mean Arterial blood pressure intubation

  Induction

• heart rate intubation

  Induction

• Post operative sedation

  every 5 minutes, up to 30minutes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine

Drug: Dexmedetomidine injection

normaL SALINE 0.9%

PLACEBO COMPARATOR

Four 50 ml syringes of .9 % Normal SALINE

Drug: Normal Saline

Interventions

Dexmedetomidine injection DRUG

Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.

Also known as: dexmedetomidine

Dexmedetomidine

Normal Saline DRUG

0.9% as placebo

normaL SALINE 0.9%

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive patients of both genders of age 17 years to 70 years who are undergoing laparoscopic cholecystectomy.
• ASA II and III

You may not qualify if:

• Patients with a prior history of cardiac disease like ischemic heart disease, valvular disorders, undergone previous valve replacements, infective endocarditis and rheumatic fever.
• Renal diseases like acute kidney injury and chronic renal diseases.
• Endocrinal diseases like pheochromocytoma, hyperthyroidism, hypothyroidism, cushing disease etc.
• 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 (BMI\>35)
• Narcotic addicts

Sponsors & Collaborators

• Dr. Ruth K.M. Pfau Civil Hospital, Karachi: lead

Study Sites (1)

Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences

Karachi, Sindh, 75520, Pakistan

Location

MeSH Terms

Conditions

Hypertension; Pneumoperitoneum

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Muhammad Imran, FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Hanya Javaid, FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Imran, FCPS

CONTACT

+923342947181; dr.imranriasat@gmail.com

Hanya Javaid, FCPS

CONTACT

+923452424442; drhanyajavaidi@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients and care provider do not know about the interventions
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registerar

Model Details: Randomised control trial

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: November 27, 2020
• Study Start: December 30, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)