The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: TBI (Traumatic Brain Injury)

Treatments: Drug: Propofol; Drug: Melatonin 10 MG Oral Tablet; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04034771

sedation in TBI

Details and patient eligibility

About

This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

Full description

38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (BIS), Then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). While (control Group) received a placebo tablets by the same wayBIS value and propofol infusion rate was recorded over 12 hours.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age group from 18 to 65
• Both sexes
• Patients on a mechanical ventilation and need sedation
• Patients who are vitally stable

Exclusion criteria

• Gastro intestinal tract impractabililty
• Pregnant female
• Vitally unstable patients who cannot tolerate propofol infusion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

propofol and melatonin

Experimental group

Description:

propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.

Treatment:

Drug: Melatonin 10 MG Oral Tablet

Drug: Propofol

propofol and placebo

Active Comparator group

Description:

propofol iv infusion and a placebo tablets through a nasogastric tube once at admission

Treatment:

Drug: Placebo oral tablet

Drug: Propofol