Dexmedetomidine for Postoperative Analgesia After Bariatr... | NCT02213159

Studies
Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

NCT02213159

Sponsor

American University of Beirut Medical Center

Status

Completed

Last Update Posted

Jul 13, 2016Estimated

Enrollment

60Actual

Phase

Phase 2Phase 3

Conditions

Obesity
Sleep Apnea
Diabetes
Hypertension

Interventions

Dexmedetomidine
Morphine

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Nov 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 8, 2014

First Submission Date that Met QC Criteria

Aug 8, 2014

First Posted Date

Aug 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2016

Last Update Posted Date

Jul 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.

Detailed Description

effect of Dexmedetomidine bolus on postoperative morphine requirements

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine	Active Comparator	prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes	Drug: Dexmedetomidine
Morphine	Active Comparator	prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes	Drug: Morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug		Dexmedetomidine	Precedex
Morphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)		At discharge from the PACU

Secondary Outcomes

Measure	Description	Time Frame
Time to first morphine requirement in PACU		in the PACU
Numeric Rating Scale (NRS) for Pain		in the PACU and at 24 hours
NRS for nausea

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body Mass Index > 40 kg/m2 or BMI > 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea
American Society of Anesthesiologists class I or II
Undergoing laparoscopic sleeve gastrectomy bariatric surgery

Exclusion Criteria:

Allergy to morphine or its derivatives
Allergy to α-2 adrenergic agonists
weight over 180 kg
history of uncontrolled hypertension
heart block greater than first degree
prolonged QT interval
clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases
received an opioid analgesic medication within a 24 h period prior to surgery
history of alcohol, drug abuse or chronic opioid intake
history of psychiatric disorder
pregnant or breastfeeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carine Zeeni, M.D.	AUBMC	Principal Investigator
Sahar Siddik, M.D.	AUBMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American University of Beirut Medical Center		Beirut			Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D012891	Sleep Apnea Syndromes
D003920	Diabetes Mellitus
D006973	Hypertension
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D009020	Morphine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided