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Completed

NCT Number: NCT03732963

Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation

investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cairo University

Cairo, 11451, Egypt

About this study

A number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time

The effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before.

The present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 -65 years
  • ASA grade I to II
  • Both sexes
  • Patients with unilateral chronic subdural hematoma
  • Patients who are vitally stable
  • Glascow coma scale 14-15

Exclusion criteria

  • Age below 50 and above 65 years.
  • Gastro intestinal tract impractabililty.
  • Patients with any substance abuse.
  • Patients with hepatic or renal insufficiency.
  • Patients on antipsychotic, anticonvulsant or anti-parkinsonian medication.
  • Vitally unstable patients who cannot tolerate propofol sedation.
  • Patients with known allergies to any of the drugs used.

Treatment and study plan

Placebo (Group P)

Drug

Group P: 20 patients will receive a placebo tablet preoperatively.

Other names: Placebo Group

Melatonin (Group M)

Drug

Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.

Other names: Melatonin Group

Primary outcomes

  1. To compare propofol consumption among both groups.

    Time frame: 24 hours Postoperative

    propofol consumption per mg among both groups.

Secondary outcomes

  1. Vital Signs

    Time frame: 24 hours Postoperative

    Blood pressure (mmHg) .

  2. Number of intraoperative patients movements.

    Time frame: 24 hours Postoperative

    Intraoperative patients movements

  3. Anesthesia recovery times /Hour in both groups.

    Time frame: 24 hours Postoperative

    Anesthesia recovery times in both groups

  4. VAS score for pain in each group

    Time frame: 24 hours Postoperative

    VAS score for pain in each group

  5. Time to first rescue analgesic in both groups.

    Time frame: 24 hours Postoperative

    Time to first rescue analgesic in both groups.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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