Trial Outcomes & Findings for Effect of Dexmedetomidine of Gastrointestinal Motility (NCT NCT04798482)

NCT ID: NCT04798482

Last Updated: 2024-04-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 minute
• Results posted on: 2024-04-26

Participant Flow

Participant milestones

Measure	Dexmedetomidine This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Dexmedetomidine: Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Dexmedetomidine This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Dexmedetomidine: Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
Overall Study Physician Decision	1
Overall Study Lost eligibility	1

Baseline Characteristics

Effect of Dexmedetomidine of Gastrointestinal Motility

Baseline characteristics by cohort

Measure	Dexmedetomidine n=22 Participants This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Dexmedetomidine: Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
Age, Categorical <=18 years	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.29 years STANDARD_DEVIATION 4.71 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · American	13 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · French	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Arabic	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Canadian	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · English	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	5 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 minute

Outcome measures

Measure

Dexmedetomidine n=20 Participants This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Dexmedetomidine: Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.

Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration

62.9 mmHg Standard Deviation 4.5

PRIMARY outcome

Timeframe: 5 minutes

Outcome measures

Measure

Dexmedetomidine n=20 Participants This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Dexmedetomidine: Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.

Intra-anal Sphincter Pressure (IASP) 5 Minutes After Dexmedetomidine Administration

45.1 mmHg Standard Deviation 3.7

PRIMARY outcome

Timeframe: 30 seconds

IASP recorded prior to administration of dexmedetomidine

Outcome measures

Measure

Dexmedetomidine n=20 Participants This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes. Dexmedetomidine: Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.

Intra-anal Sphincter Pressure (IASP) Baseline Measurement

80.5 mmHg Standard Deviation 5.9

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keira Mason MD

Boston Children's Hospital

Phone: 617-355-5775

Email: keira.mason@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place