NCT02213159

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

August 8, 2014

Last Update Submit

July 12, 2016

Conditions

ObesitySleep ApneaDiabetesHypertension

Keywords

Dexmedetomidinebariatric surgerypostoperative painmorphine consumptionQuality of recovery

Outcome Measures

Primary Outcomes (1)

  • Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)

    At discharge from the PACU

Secondary Outcomes (10)

  • 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

    in the PACU

  • incidence of pruritus

    in the PACU

  • incidence of vomiting or retching

    in the PACU

  • +5 more secondary outcomes

Study Arms (2)

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

DexmedetomidineDRUG
Also known as: Precedex
Dexmedetomidine
MorphineDRUG
Morphine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

ObesitySleep Apnea SyndromesDiabetes MellitusHypertensionPain, Postoperative

Interventions

DexmedetomidineMorphine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Carine Zeeni, M.D.

    AUBMC

    PRINCIPAL INVESTIGATOR

  • Sahar Siddik, M.D.

    AUBMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 11, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

July 13, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)