Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
Primary Purpose
Monitored Anaesthesia Care, Loco-regional Chronic Subdural Hematoma Evacuation
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Placebo (Group P)
Melatonin (Group M)
Sponsored by
About this trial
This is an interventional supportive care trial for Monitored Anaesthesia Care focused on measuring Oral Melatonin Premedication
Eligibility Criteria
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo (Group P)
Melatonin (Group M)
Arm Description
Group P: 20 patients will receive a placebo tablet preoperatively.
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
Outcomes
Primary Outcome Measures
To compare propofol consumption among both groups.
propofol consumption per mg among both groups.
Secondary Outcome Measures
Vital Signs
Blood pressure (mmHg) .
Number of intraoperative patients movements.
Intraoperative patients movements
Anesthesia recovery times /Hour in both groups.
Anesthesia recovery times in both groups
VAS score for pain in each group
VAS score for pain in each group
Time to first rescue analgesic in both groups.
Time to first rescue analgesic in both groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03732963
Brief Title
Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
Official Title
Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monitored Anaesthesia Care, Loco-regional Chronic Subdural Hematoma Evacuation
Keywords
Oral Melatonin Premedication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
(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
Masking
ParticipantCare ProviderInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (Group P)
Arm Type
Placebo Comparator
Arm Description
Group P: 20 patients will receive a placebo tablet preoperatively.
Arm Title
Melatonin (Group M)
Arm Type
Active Comparator
Arm Description
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
Intervention Type
Drug
Intervention Name(s)
Placebo (Group P)
Other Intervention Name(s)
Placebo Group
Intervention Description
Group P: 20 patients will receive a placebo tablet preoperatively.
Intervention Type
Drug
Intervention Name(s)
Melatonin (Group M)
Other Intervention Name(s)
Melatonin Group
Intervention Description
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
Primary Outcome Measure Information:
Title
To compare propofol consumption among both groups.
Description
propofol consumption per mg among both groups.
Time Frame
24 hours Postoperative
Secondary Outcome Measure Information:
Title
Vital Signs
Description
Blood pressure (mmHg) .
Time Frame
24 hours Postoperative
Title
Number of intraoperative patients movements.
Description
Intraoperative patients movements
Time Frame
24 hours Postoperative
Title
Anesthesia recovery times /Hour in both groups.
Description
Anesthesia recovery times in both groups
Time Frame
24 hours Postoperative
Title
VAS score for pain in each group
Description
VAS score for pain in each group
Time Frame
24 hours Postoperative
Title
Time to first rescue analgesic in both groups.
Description
Time to first rescue analgesic in both groups.
Time Frame
24 hours Postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdalla Mohamed, M.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11451
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not Now
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Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
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