The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study

NCT06414395 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PT (704)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol is currently the most common drug used but has drawbacks like narrow therapeutic window and potential complications. Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression. Studies are ongoing to find the optimal use of dexmedetomidine for these procedures. A combination of propofol and dexmedetomidine might be ideal, but the best balance between the two drugs needs further investigation.

Conditions

GIT Endoscopy; Procedural Sedation

Outcome Measures

Primary Outcomes (1)

• • Recovery time of each group: the time from ending the infusions till a modified Aldrete score (MAS) score of ≥ 9 is reached.

  4 months

Study Arms (4)

The Dexmedetomidine Group D1

EXPERIMENTAL

D1 group will receive 1µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg.

Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection

The Dexmedetomidine Group D 0.5

EXPERIMENTAL

D 0.5 group will receive 0.5 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg

Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection

The Dexmedetomidine Group D0.25

EXPERIMENTAL

D 0.25 group will receive 0.25 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg

Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection

The Dexmedetomidine Group D 0

PLACEBO COMPARATOR

D 0 group will receive a placebo saline infusion over 10 minutes and then will receive 50 ml of normal saline as a placebo

Other: C group: Patients received saline infusion over 10 minutes

Interventions

Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection DRUG

The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study

The Dexmedetomidine Group D 0.5; The Dexmedetomidine Group D0.25; The Dexmedetomidine Group D1

C group: Patients received saline infusion over 10 minutes OTHER

the group will receive normal saline infusion over 10 minutes.

Also known as: Placebo

The Dexmedetomidine Group D 0

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65
• Both sexes
• ASA I-II
• BMI \<35

You may not qualify if:

• Patients' refusal to participate
• ASA III-IV
• BMI \> 35
• Patients who are considered high aspiration risk, e.g., gastric outlet obstruction
• Allergy to any medications used
• Diabetics
• Any patient receiving cardioactive drugs, e.g., Beta blockers, Calcium channel blockers, Inhaled B2 bronchodilators)
• Patients with Pacemakers or heart rate below 50 beat/min
• Pregnant women
• Habitual Drug abusers
• Patients who had to be intubated during the procedure.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Cairo, Giza Governorate, 12411, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Injections

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Sameh M. Elaidy, Msc.

CONTACT

1111776906; sameh.elaidy@hotmail.com

Nabawya Kamel, Proffessor

CONTACT

1066175989; n.kamal21@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be performed using computer generated numbers with Random Allocation Software in a 1:1:1:1 ratio. The patient's allocation and drug administration instructions will be kept in consequentially numbered opaque envelopes (equal number per each group). A colleague, not participating to the study, will be responsible for study drugs preparation \& labelling.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: This study hypothesizes that lower doses of dexmedetomidine (0.25 µg.kg-1 or the 0.5 µg.kg-1) can co-produce adequate propofol sparing sedation that is not inferior to the standard dose of 1µg.kg-1 and without significantly prolonging the propofol recovery time or increasing the total propofol consumption.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: May 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

EG (1)