Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.

• Sponsor: Federal University of Minas Gerais (Other)
• Overall Status: Completed
• CT.gov ID: NCT02631525
• Collaborator: Baxter Healthcare Corporation (Industry), Medtronic - MITG (Industry)
• Enrollment: 40
• Arms: 2
• Duration (Months): 16

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Delayed Emergence From Anesthesia	Drug: Desflurane; Drug: Propofol	Phase 4

Detailed Description

It is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. The patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. Bispectral index (BIS) monitoring guided the anesthesia by setting target BIS range value between 40 and 60. Anesthetics were adjusted to reached that. Primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). Secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. Protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.Post-anesthesia care unit recovery data were also recorded: Ramsay sedation scale; vital signs, post-operative pain; morphine consumption.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: REM-PRO Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.	Drug: Propofol; Total intravenous anesthesia based on propofol; Other Names: Diprivan
Active Comparator: REM-DES Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.	Drug: Desflurane; Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring

Outcome Measures

Primary Outcome Measures

1. Extubation Time [Time from anesthetic discontinuation to endotracheal tube cuff deflation]

   Time from anesthetic discontinuation to endotracheal tube cuff deflation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of Minas Gerais
• Baxter Healthcare Corporation
• Medtronic - MITG

Investigators

• Principal Investigator: Renato S Gomez, PhD, Professor of the Medicine School of the Federal University of Minas Gerais

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;(6):CD003843. doi: 10.1002/14651858.CD003843.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 Sep 26;9:CD003843.
• 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.
• 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.

• Responsible Party: Renato Santiago Gomez, Head of surgery department of the Medical School of the Federal University of Minas Gerais, Federal University of Minas Gerais
• ClinicalTrials.gov Identifier: NCT02631525
• Other Study ID Numbers: CAAE - 31820014.8.0000.5149
• First Posted: Dec 16, 2015
• Last Update Posted: Aug 25, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Renato Santiago Gomez, Head of surgery department of the Medical School of the Federal University of Minas Gerais, Federal University of Minas Gerais: Airway extubation; Anesthesia Recovery Period; Desflurane; Propofol; Intravenous anesthesia; Balanced Anesthesia
• Additional relevant MeSH terms: Delayed Emergence from Anesthesia; Propofol; Desflurane

Study Results

Participant Flow

Arm/Group Title	REM-PRO	REM-DES
Arm/Group Description	Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. Propofol: Total intravenous anesthesia based on propofol	Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane. Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	REM-PRO	REM-DES	Total
Arm/Group Description	Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. Propofol: Total intravenous anesthesia based on propofol	Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane. Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (15)	46 (11)	50 (14)
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	40 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Brazil	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Extubation Time
Description	Time from anesthetic discontinuation to endotracheal tube cuff deflation
Time Frame	Time from anesthetic discontinuation to endotracheal tube cuff deflation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REM-PRO	REM-DES
Arm/Group Description	Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. Propofol: Total intravenous anesthesia based on propofol	Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane. Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
Measure Participants	19	20
Mean (Full Range) [minutes]	9.5	6.2

Adverse Events

Arm/Group Title	REM-PRO		REM-DES
Arm/Group Description	Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. Propofol: Total intravenous anesthesia based on propofol		Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane. Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
All Cause Mortality
	REM-PRO		REM-DES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)
Serious Adverse Events
	REM-PRO		REM-DES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	REM-PRO		REM-DES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.