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The Effect of Dexmedetomidine, Melatonin and Pregabalin

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05829148
Enrollment
120
Registered
2023-04-25
Start date
2023-05-01
Completion date
2024-11-20
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Sinus Surgery

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

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

Interventions

DRUGDexmedetomidine

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

DRUGMelatonin

Melatonin

DRUGPregabalin

Pregabalin

DRUGPlacebo

Placebo

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Relieve2 hours post operativeAssessment 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,

Secondary

MeasureTime frameDescription
controlled pulse rateFrom base line to 1 hour after the end of the operationHemodynamics stability
controlled blood pressureFrom base line to 1 hour after the end of the operationHemodynamics stability

Countries

Egypt

Contacts

Primary ContactTarek Mounir, Professor
tarekmunir99@gmail.com+201012140880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026