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

Loco-regional Chronic Subdural Hematoma Evacuation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732963
• Other study ID #: N 45-2018/Ms
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2018
• Est. completion date: November 7, 2018

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 7, 2018
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic
• Loco-regional Chronic Subdural Hematoma Evacuation
• Monitored Anaesthesia Care

Intervention

Drug:
• Placebo (Group P)
Group P: 20 patients will receive a placebo tablet preoperatively.
• Melatonin (Group M)
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare propofol consumption among both groups.	propofol consumption per mg among both groups.	24 hours Postoperative
Secondary	Vital Signs	Blood pressure (mmHg) .	24 hours Postoperative
Secondary	Number of intraoperative patients movements.	Intraoperative patients movements	24 hours Postoperative
Secondary	Anesthesia recovery times /Hour in both groups.	Anesthesia recovery times in both groups	24 hours Postoperative
Secondary	VAS score for pain in each group	VAS score for pain in each group	24 hours Postoperative
Secondary	Time to first rescue analgesic in both groups.	Time to first rescue analgesic in both groups.	24 hours Postoperative