Nitrous Oxide Added at the End of Sevoflurane Anesthesia and Recovery

NCT03420586 | Completed

• 1 other identifier: 01-5623-7/17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Addition of nitrous oxide N2O towards the end of prolonged isoflurane anesthesia hastens patients recovery. The hypothesis is that the addition of N2O at the end of prolonged sevoflurane anaesthesia also hastens early recovery without increasing the frequencies and intensity of PONV and improves quality of recovery.

Conditions

Elective Surgical Procedures; Laparoscopy; Laparotomy; Anesthesia, General; Anesthesia Recovery Period

Keywords

Anesthetics, Inhalation; Anesthesia Recovery Period; Postoperative Nausea and Vomiting; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Early recovery (awakening) in the operation room (OR)

  eye opening (in minutes), following verbal commands (in minutes), time to extubation (in minutes ), orientation to time and place (in minutes)

  15 minutes

Secondary Outcomes (3)

• Postoperative nausea and vomiting

  24 hours

• Quality of recovery

  72 hours

• Postoperative pain

  24 hours

Other Outcomes (4)

• Postoperative sedation

  2 hours

• Postoperative nausea and vomiting

  24 hours

• Postoperative pain

  24 hours

Study Arms (2)

Nitrous oxide Group

ACTIVE COMPARATOR

The nitrous oxide group (GN2O) will receive air in 30% O2 during general anesthesia until the last 30 min of surgery, when 70% N2O in 30% O2 will be administered.

Drug: Nitrous Oxide

Oxygen Group

NO INTERVENTION

The Oxygen group will receive gas carrier mixture consisting of air in 30% O2 during general anesthesia.

Interventions

Nitrous Oxide DRUG

The nitrous oxide group (GN2O) will receive 70% N2O in 30% O2 at the end of surgery.

Nitrous oxide Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, American Society of Anesthesiologists Physical status ASA PS I-III, scheduled for laparotomic and laparoscopic surgery expected to last 2 hours or more who can understand and signed informed consent.

You may not qualify if:

• Patients who will be discharged within 72 hours after surgery
• Patients on intensive care within few months before the study enrollment
• Diseases that impair gastric motility (diabetes mellitus, chronic cholecystitis, gastric and intestinal disease, neuromuscular disorders, neuropathies, liver dysfunction)
• Vestibular disease; history of migraine headaches, central nervous system injury
• Renal impairment
• Patients on antihistamines, antipsychotics, contraceptives, steroids within 72 hours before surgery
• Known hypersensitivity to drugs used in the study protocol
• Alcoholism, and/or opioid addiction
• Conditions that can influence the incidence of PONV, postoperative pain or morbidity (e.g., significant intraoperative surgery complications), intraoperative drug allergy, severe intraoperative hypotension, perioperative hypoxia, excessive blood loss, difficult intubation

Sponsors & Collaborators

• General Hospital Zadar: lead

Study Sites (1)

General Hospital Zadar

Zadar, 23000, Croatia

Location

Related Publications (7)

• Mraovic B, Simurina T, Gan TJ. Nitrous oxide added at the end of isoflurane anesthesia hastens early recovery without increasing the risk for postoperative nausea and vomiting: a randomized clinical trial. Can J Anaesth. 2018 Feb;65(2):162-169. doi: 10.1007/s12630-017-1013-y. Epub 2017 Nov 17.

  PMID: 29150782 BACKGROUND

• Peyton PJ, Wu CY. Nitrous oxide-related postoperative nausea and vomiting depends on duration of exposure. Anesthesiology. 2014 May;120(5):1137-45. doi: 10.1097/ALN.0000000000000122.

  PMID: 24401771 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

  PMID: 9895071 BACKGROUND

• Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.

  PMID: 22290456 BACKGROUND

• Agoliati A, Dexter F, Lok J, Masursky D, Sarwar MF, Stuart SB, Bayman EO, Epstein RH. Meta-analysis of average and variability of time to extubation comparing isoflurane with desflurane or isoflurane with sevoflurane. Anesth Analg. 2010 May 1;110(5):1433-9. doi: 10.1213/ANE.0b013e3181d58052.

  PMID: 20418303 BACKGROUND

• Jones PM, Bainbridge D, Chu MWA, Fernandes PS, Fox SA, Iglesias I, Kiaii B, Lavi R, Murkin JM. Comparison of isoflurane and sevoflurane in cardiac surgery: a randomized non-inferiority comparative effectiveness trial. Can J Anaesth. 2016 Oct;63(10):1128-1139. doi: 10.1007/s12630-016-0706-y. Epub 2016 Jul 27.

  PMID: 27465213 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration; Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Tatjana Simurina, MD, PhD

  GH Zadar, Dpt. of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

• Boris Mraovic, Prof, MD

  Anesthesiology & Parioperative Medicine School of Medicine, University of Missouri, Columbia, US

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized into two groups by computer-generated random numbers. Each allocation number will be concealed in an opaque envelope before the start of the surgery and will be revealed 30 min before the end of the operation. Early recovery (eye opening, following verbal commands, time to extubation, orientation to time and place) will be recorded by an anesthesiologist blinded to the anesthesia technique. The same anesthesiologist blinded to the anesthesia technique will collect all postoperative data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Model: Parallel Assignment

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 5, 2018
• Study Start: February 7, 2018
• Primary Completion: July 10, 2021
• Study Completion: July 25, 2021
• Last Updated: November 9, 2022

Record last verified: 2020-08

Locations

CR (1)