NCT02631525

Brief Summary

Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 25, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

December 4, 2015

Results QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

Delayed Emergence From Anesthesia

Keywords

Airway extubationAnesthesia Recovery PeriodDesfluranePropofolIntravenous anesthesiaBalanced Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Extubation Time

    Time from anesthetic discontinuation to endotracheal tube cuff deflation

    Time from anesthetic discontinuation to endotracheal tube cuff deflation

Study Arms (2)

REM-PRO

ACTIVE COMPARATOR

Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.

Drug: Propofol

REM-DES

ACTIVE COMPARATOR

Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.

Drug: Desflurane

Interventions

DesfluraneDRUG

Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring

REM-DES
PropofolDRUG

Total intravenous anesthesia based on propofol

Also known as: Diprivan
REM-PRO

Eligibility Criteria

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

You may qualify if:

  • Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.

You may not qualify if:

  • History of: illegal drug and alcohol abuse
  • Pregnancy on course or suspicion of
  • Neuromuscular disorders
  • Cerebral vascular disease
  • Dysphagia
  • Dysphonia
  • Gastroesophageal reflux disease
  • Previous larynx and/or upper gastrointestinal tract surgery
  • Allergy to any drug to be used and malignant hyperthermia.
  • Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.
  • Patients unable to swallow 20 ml of water in an upright position were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wu ZF, Jian GS, Lee MS, Lin C, Chen YF, Chen YW, Huang YS, Cherng CH, Lu CH. An analysis of anesthesia-controlled operating room time after propofol-based total intravenous anesthesia compared with desflurane anesthesia in ophthalmic surgery: a retrospective study. Anesth Analg. 2014 Dec;119(6):1393-406. doi: 10.1213/ANE.0000000000000435.

    PMID: 25211391BACKGROUND

  • Mckay RE, Large MJC, Balea MC, Mckay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700. doi: 10.1213/01.ANE.0000146514.65070.AE.

    PMID: 15728054BACKGROUND

  • Wachtel RE, Dexter F, Epstein RH, Ledolter J. Meta-analysis of desflurane and propofol average times and variability in times to extubation and following commands. Can J Anaesth. 2011 Aug;58(8):714-24. doi: 10.1007/s12630-011-9519-1. Epub 2011 Jun 1.

    PMID: 21630118BACKGROUND

  • Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.

    PMID: 24937564BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

DesfluranePropofol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Dr Renato Gomez
Organization
Universidade federal de Minas Gerais
renatogomez2000@yahoo.com.br
553134099760

Study Officials

  • Renato S Gomez, PhD

    Professor of the Medicine School of the Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of surgery department of the Medical School of the Federal University of Minas Gerais

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 16, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 25, 2020

Results First Posted

August 25, 2020

Record last verified: 2020-08