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

NCT03732963 | Completed Phase 1 DMC

• 1 other identifier: N 45-2018/Ms
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Monitored Anaesthesia Care; Loco-regional Chronic Subdural Hematoma Evacuation

Keywords

Oral Melatonin Premedication

Outcome Measures

Primary Outcomes (1)

• To compare propofol consumption among both groups.

  propofol consumption per mg among both groups.

  24 hours Postoperative

Secondary Outcomes (5)

• Vital Signs

  24 hours Postoperative

• Number of intraoperative patients movements.

  24 hours Postoperative

• Anesthesia recovery times /Hour in both groups.

  24 hours Postoperative

• VAS score for pain in each group

  24 hours Postoperative

• Time to first rescue analgesic in both groups.

  24 hours Postoperative

Study Arms (2)

Placebo (Group P)

PLACEBO COMPARATOR

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

Drug: Placebo (Group P)

Melatonin (Group M)

ACTIVE COMPARATOR

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

Drug: Melatonin (Group M)

Interventions

Placebo (Group P) DRUG

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

Also known as: Placebo Group

Placebo (Group P)

Melatonin (Group M) DRUG

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

Also known as: Melatonin Group

Melatonin (Group M)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ahmed Abdalla Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be done via computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of series will be unknown to the investigators and the group assignment will be kept in a set of concealed envelopes each bearing only the case number on the outside. Prior to the start of the study, the appropriately numbered envelopes will be opened by the nurse, the card will determine the assigned intervention for each patient, which will be prepared by a clinical pharmacist with no other role in the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Model Details: (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland. It is primarily responsible for the sleep awake cycle as its level decreases in the morning and increases by night; owing to reduced light intensity, leading to circadian rhythm. It provides circadian and seasonal timing through activation of G protein-coupled receptors (GPCRs) in target tissues. Melatonin exerts its hypnotic effects through the activation of the MT1 and MT2 melatonin receptors

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: November 7, 2018
• Study Start: September 5, 2018
• Primary Completion: November 5, 2018
• Study Completion: November 7, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

EG (1)