NCT04942340

Brief Summary

In this study, the investigators will explore Atipamezole \& caffeine's ability to facilitate the emergence from anesthesia. Each subject will visit UChicago 4 times. The first time for informed consent. The second time for a complete physical exam to ensure that the subjects are healthy. Then there are 2 sedation sessions. Subjects get an honorarium for each sedation session.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

June 11, 2021

Last Update Submit

May 15, 2023

Conditions

Emergence From Anesthesia

Keywords

AtipamezoleCaffeineSedation RecoveryAnesthesiaPrecedex

Outcome Measures

Primary Outcomes (1)

  • The time when the drug injections are complete to the awakening of the subject.

    We will record the time until the subject's eyes open, and the time until the subject can respond to the command to grip the hand of the attending physician

    1 Day

Secondary Outcomes (2)

  • Measure Cognitive Function

    This test will be repeated every 15 Minutes for 90 Minutes after the subject has awakened]

  • Measure Reaction Time

    This test will be repeated every 15 Minutes for 90 Minutes after the subject has awakened]

Study Arms (2)

Phase 1: Atipamezole & caffeine's in a 1:1 ratio

ACTIVE COMPARATOR

Is this arm, subjects will be randomized to IV administration of Atipamezole \& caffeine's in a 1:1 ratio

Drug: Atipamezole & Caffeine

Phase 1: Precedex & Saline in a 1:1 ratio

PLACEBO COMPARATOR

Is this arm, subjects will be randomized to receive IV administration of Precedex \& Saline in a 1:1 ratio

Drug: Dexmedetomidine Hydrochloride & Saline

Interventions

Atipamezole & CaffeineDRUG

In this arm, subjects will be infused with Atipamezole (2 g/kg) and caffeine (15 mg/kg) across 5 minutes

Also known as: Antisedan
Phase 1: Atipamezole & caffeine's in a 1:1 ratio
Dexmedetomidine Hydrochloride & SalineDRUG

In this arm, subjects will be infused with Precedex \& Saline at 15 mg/kg across 5 minutes

Also known as: Precedex
Phase 1: Precedex & Saline in a 1:1 ratio

Eligibility Criteria

Age22 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>21 or \<40
  • ASA physical status = 1 (normal healthy patient without systematic diseases or conditions)
  • Metabolic Equivalents of Functional Capacity (METs) \> 5
  • Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \< 3 items- high risk of OSA
  • No history Arrhythmia, such as heart block (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
  • BMI \<30 kg/m2
  • No history of any mental illness
  • No history of drugs or alcohol abuse (an urine drug screen test required)

You may not qualify if:

  • Age \<21 or \>40
  • ASA physical status \> 1 (normal healthy patient with systematic diseases or conditions)
  • Metabolic Equivalents of Functional Capacity (METs)\<5
  • High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA
  • History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
  • BMI \>30 kg/m2
  • History of any mental illness
  • History of drugs or alcohol abuse (an urine drug screen test required)
  • Female subjects with positive urine pregnancy test, which will be performed before each sedation session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

atipamezoleCaffeineDexmedetomidineSodium Chloride

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingImidazolesAzolesHeterocyclic Compounds, 1-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The anesthesiologists will be blinded to the medication injected to the subject since the drugs or normal saline are prepared by the pharmacists in the OR pharmacy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: TBA
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 28, 2021

Study Start

May 1, 2023

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations

US(1)