NCT06014359

Brief Summary

This randomized study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation and pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

August 27, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 23, 2023

Last Update Submit

August 30, 2023

Conditions

DexmedetomidineHemodynamicsLaparoscopic Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic response to laryngoscope, and pneumoperitoneum.

    Heart rate (HR) and non-invasive mean arterial blood pressure (MAP) changes before nebulization, after nebulization, immediately after induction, after intubation at (1-3-6 minutes), post-pneumoperitoneum(T0) then every 15 minutes till end of the surgery.

    Intraoperative

Secondary Outcomes (4)

  • Degree of sedation

    Just after nebulization

  • Amount of opioid consumption

    24 hours postoperative

  • Amount of fentanyl consumption

    Intraoperative

  • Postoperative pain

    24 hours postoperative

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients of this group will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.

Drug: Saline

Study group

EXPERIMENTAL

Patients of this group will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.

Drug: Dexmedetomidine

Interventions

SalineDRUG

Patients will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.

Control group
DexmedetomidineDRUG

Patients will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.

Study group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • This study will include 90 adult morbidly obese patients of both sex with BMI (40-50), (ASA) III physical status, aged between 18 -50 years scheduled for elective laparoscopic bariatric surgery under general anesthesia.

You may not qualify if:

  • Patient's refusal.
  • Decompensated hepatic or renal or cardiac disease.
  • Expected difficult airway management.
  • Uncontrolled hypertension.
  • Psychiatric disease.
  • Sever pulmonary disorders.
  • Patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Sodium ChlorideDexmedetomidine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Abdelhamed I Badreldin, MBBCH

    Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelhamed I Badreldin, MBBCH

CONTACT

00201090690631ai0751294@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 28, 2023

Study Start

August 27, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
after the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations

EG(1)