The Effect of Dexmedetomidine, Melatonin and Pregabalin

April 24, 2023 updated by: Egymedicalpedia

Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Functional Endoscopic Sinus Surgery (FESS) is done via endoscope and the area is highly vascular thus it becomes important to minimize bleeding, hence we require hypotensive anesthesia.

Dexmedetomidine (a highly selective α2-receptor agonist that has sedative, analgesic, anxiolytic, and opioid sparing effects without significant respiratory depression) it also reduces the need for inhaled anesthetics. dexmedetomidine also minimizes postoperative opioid consumption as well as nausea, vomiting, and anxiety.

Melatonin is a neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. It possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin (available in 5mg tablet form) fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting.

Pregabalin, whose structure is similar to the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), possesses analgesic and anxiolytic activities and is effective in alleviating the neuropathic component of acute nociceptive pain of surgery. It has also been used as premedication to attenuate the hemodynamic stress response to laryngoscopy and intubation and to decrease intraoperative anesthetic requirement

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al-Azhar University hospitals
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamed Abdel-Gawad, Assist.Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine Group
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
Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
Active Comparator: Melatonin Group
This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation.
Drug: Melatonin
Melatonin
Active Comparator: Pregabalin Group
This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation..
Drug: Pregabalin
Pregabalin
Placebo Comparator: Control Group
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
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relieve
Time Frame: 2 hours post operative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
controlled pulse rate
Time Frame: From base line to 1 hour after the end of the operation
Hemodynamics stability
From base line to 1 hour after the end of the operation
controlled blood pressure
Time Frame: From base line to 1 hour after the end of the operation
Hemodynamics stability
From base line to 1 hour after the end of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egymedicalpedia

Investigators

  • Study Chair: Mohamed AbdelGawad, Assist.Prof, Al-Azhar University, Faculty of medicine for boys

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 20, 2024

Study Registration Dates

First Submitted

April 8, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alaa Abdel-Khalek

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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