NCT07475156

Brief Summary

The aim of this study is to illuminate the effect of combination of dexmedetomidine and oral melatonin versus the use of dexmedetomidine infusion alone on the improving of post-operative delirium (POD) on patients undergoing open brain surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 12, 2026

Last Update Submit

March 14, 2026

Conditions

Post Operative Delerium

Keywords

Post operative deleriumDexmedetomidineMelatoninOpen brain surgeryCombination

Outcome Measures

Primary Outcomes (1)

  • The incidence of POD

    Through calculation of CAM-ICU Score \& RASS score of patient

    Perioperatively

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Dexmedetomidine alone

Drug: Dexmedetomidine (DEX)

Combination Group

ACTIVE COMPARATOR

Combination of Dexmedetomidine \& Melatonin

Drug: Dexmedetomidine (DEX)Drug: Melatonin

Interventions

Dexmedetomidine (DEX)DRUG

Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr)

Combination GroupControl Group
MelatoninDRUG

Orall Melatonin (3 mg/tablet)

Combination Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 30 - 60 years
  • Sex: Both sexes
  • Patients with open space occupying lesions or hematoma.

You may not qualify if:

  • Refusal of the patient to give written informed consent.
  • History of allergy to the medications used in the study.
  • Psychiatric disorder.
  • Any form of drug addiction.
  • Patients receiving any anti-psychotic medications.
  • History of previous brain insult (Ischemic or haemorrhagic infarctions).
  • Pre-operative dementia.
  • History of malignant hyperthermia
  • Patient's suffering from bradycardia
  • Patient's suffering from hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine , Ain Shams University

Cairo, Abbassia, 1181, Egypt

Location

MeSH Terms

Interventions

DexmedetomidineMelatonin

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

March 16, 2026

Study Start

August 1, 2025

Primary Completion

January 15, 2026

Study Completion

February 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

EG(1)