The Effect of Dexmedetomidine, Melatonin and Pregabalin

NCT05829148 | Unknown Early Phase 1 DMC

• 1 other identifier: Alaa Abdel-Khalek
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc. Since all these drugs have certain limitations there was a search for more safe and effective drug

Conditions

Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• Pain Relieve

  Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain,

  2 hours post operative

Secondary Outcomes (2)

• controlled pulse rate

  From base line to 1 hour after the end of the operation

• controlled blood pressure

  From base line to 1 hour after the end of the operation

Study Arms (4)

Dexmedetomidine Group

ACTIVE COMPARATOR

This Group about 30 patients will receive dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.2µg/kg/h throughout the surgery .

Drug: Dexmedetomidine

Melatonin Group

ACTIVE COMPARATOR

This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation.

Drug: Melatonin

Pregabalin Group

ACTIVE COMPARATOR

This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation..

Drug: Pregabalin

Control Group

PLACEBO COMPARATOR

This Group about 30 patients will receive oral starch tablet as a control. Heart rate (HR) and blood pressure values will be recorded at various intervals.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus

Dexmedetomidine Group

Melatonin DRUG

Melatonin

Melatonin Group

Pregabalin DRUG

Pregabalin

Pregabalin Group

Placebo DRUG

Placebo

Control Group

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients undergoing Functional endoscopic sinus surgery (ASA I \& II)

You may not qualify if:

• \- Hepatic, renal, endocrinal, hematological disorders.
• BMI\>30 kg/m2.
• Patients receiving magnesium supplementation, anticonvulsant drugs or antipsychotic drugs.
• Chronic use of opioids.
• Current treatment with β-blocker or calcium channel blocker.
• Known allergies to any of study drugs.
• Patients refusal to the study

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Melatonin; Pregabalin

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed AbdelGawad, Assist.Prof

  Al-Azhar University, Faculty of medicine for boys

  STUDY CHAIR

Central Study Contacts

Tarek Mounir, Professor

CONTACT

+201012140880; tarekmunir99@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: April 25, 2023
• Study Start: May 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 20, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

EG (1)