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

Delayed Emergence From Anesthesia Clinical Trial

Official title:

A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631525
• Other study ID #: CAAE - 31820014.8.0000.5149
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2020
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence From Anesthesia

Intervention

Drug:
• Desflurane
Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
• Propofol
Total intravenous anesthesia based on propofol

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Baxter Healthcare Corporation, Medtronic - MITG

References & Publications (4)

McKay RE, Large MJ, Balea MC, McKay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700, table of contents. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation Time	Time from anesthetic discontinuation to endotracheal tube cuff deflation	Time from anesthetic discontinuation to endotracheal tube cuff deflation