NCT02652312

Brief Summary

The aim of this study is to calculate desflurane consumption when combined with intraoperative dexmedetomidine infusion guided by bispectral index (BIS)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

January 6, 2016

Last Update Submit

November 9, 2016

Conditions

Anesthesia

Keywords

DexmedetomidineDesfluraneBispectral Index BIS

Outcome Measures

Primary Outcomes (1)

  • desflurane consumption (ml)

    Calculation of desflurane consumption during the intraoperative period

    Intraoperative

Secondary Outcomes (3)

  • Heart Rate (Beat/min)

    Intraoperative

  • Blood Pressure (mm Hg)

    Intraoperative

  • Fentanyl consumption (ug)

    Intraoperative

Study Arms (2)

Group 'D'

ACTIVE COMPARATOR

Dexmedetomidine group Patients received dexmedetomidine (2 ml diluted in 18 ml of saline) IV in a dose of 1 mcg/kg over 10 minutes. A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour was infused. Ondansetron: 0.15 mg/kg intravenous preoperative. Fentanyl: 1.5 μg/kg intraoperative Propofol: 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia. Atracurium: 0.5 mg/kg IV. Desflurane: 1 MAC concentration. Diclofenac sodium: 1 mg/kg for postoperative analgesia.

Drug: DexmedetomidineProcedure: OndansetronProcedure: fentanylProcedure: propofolProcedure: AtracuriumProcedure: diclofenac sodiumProcedure: desflurane

Group 'P'

PLACEBO COMPARATOR

Placebo group Patients received similar volume of normal saline as the bolus and maintenance infusion as group D. Ondansetron: 0.15 mg/kg intravenous preoperative. Fentanyl: 1.5 μg/kg intraoperative Propofol: 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia. Atracurium: 0.5 mg/kg IV. Desflurane: 1 MAC concentration. Diclofenac sodium: 1 mg/kg for postoperative analgesia.

Drug: PlaceboProcedure: OndansetronProcedure: fentanylProcedure: propofolProcedure: AtracuriumProcedure: diclofenac sodiumProcedure: desflurane

Interventions

DexmedetomidineDRUG

A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered

Also known as: Precedex, Dexdor
Group 'D'
PlaceboDRUG

A maintenance dose of 20 mL with normal saline will be administered at a rate similar to that of dexmedetomidine

Also known as: placebo effect
Group 'P'
OndansetronPROCEDURE

0.15 mg/kg intravenous (IV) will be given as a pre-medication

Also known as: Zofran
Group 'D'Group 'P'
fentanylPROCEDURE

1.5 μg/kg intraoperative

Also known as: Sublimaze,Actiq, Durogesic, Duragesic
Group 'D'Group 'P'
propofolPROCEDURE

10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia

Also known as: Diprivan
Group 'D'Group 'P'
AtracuriumPROCEDURE

0.5 mg/kg IV for endotracheal intubation

Also known as: Atracurium besilate
Group 'D'Group 'P'
diclofenac sodiumPROCEDURE

1 mg/kg for postoperative analgesia

Also known as: Voltaren
Group 'D'Group 'P'
desfluranePROCEDURE

1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia

Also known as: Suprane
Group 'D'Group 'P'

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) status of I and II
  • undergoing elective laparoscopic cholecystectomy

You may not qualify if:

  • history of psychiatric/neurological illness
  • cardiovascular disease
  • morbid obese patients
  • pregnant and nursing women
  • known allergic reaction to any of the study medication
  • recent use of sedatives or analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

Related Publications (3)

  • Harsoor SS, Rani DD, Lathashree S, Nethra SS, Sudheesh K. Effect of intraoperative Dexmedetomidine infusion on Sevoflurane requirement and blood glucose levels during entropy-guided general anesthesia. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):25-30. doi: 10.4103/0970-9185.125693.

    PMID: 24574589BACKGROUND

  • Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.

    PMID: 11046225BACKGROUND

  • Nishibe S, Imanishi H, Mieda T, Tsujita M. The effects of dexmedetomidine administration on the pulmonary artery pressure and the transpulmonary pressure gradient after the bidirectional superior cavopulmonary shunt. Pediatr Cardiol. 2015 Jan;36(1):151-7. doi: 10.1007/s00246-014-0979-2. Epub 2014 Aug 12.

    PMID: 25113519BACKGROUND

MeSH Terms

Interventions

DexmedetomidinePlacebo EffectOndansetronFentanylPropofolAtracuriumDiclofenacDesflurane

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEffect Modifier, EpidemiologicEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPiperidinesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzylisoquinolinesIsoquinolinesPhenylacetatesAcids, CarbocyclicCarboxylic AcidsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Abla El Hadidy, PhD

    Theodor Bilharz Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 11, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)