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Nitrous Oxide Added at the End of Sevoflurane Anesthesia and Recovery (SEVONATE)

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ClinicalTrials.gov Identifier: NCT03420586
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
General Hospital Zadar

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.

Condition or disease Intervention/treatment Phase
Elective Surgical Procedures Laparoscopy Laparotomy Anesthesia, General Anesthesia Recovery Period Drug: Nitrous Oxide Not Applicable

Detailed Description:
The investigators will include 100 adult patients, American Society of Anesthesiologists (ASA) physical status I-III, who will be scheduled for elective laparotomies or laparoscopic surgeries under sevoflurane anesthesia lasting 120 minutes or longer. After written informed consent participants will be randomized into two groups: GO2 - air in 30% oxygen and GN2O - the same mixture until the last 30 minutes of surgery when 70% N2O in 30% oxygen will be used. General anesthesia will be performed with propofol and fentanyl for anesthesia induction, rocuronium for muscle relaxation and volatile anesthetic sevoflurane for maintenance. The participants will be extubated in the operation room (OR) after they open their eyes and follow commands. Postanesthetic recovery score by Aldrete, Ramsay sedation scale (RSS), and Simplified postoperative nausea and vomiting impact scale score by Myles (PONV ISS) will be used to assess recovery in PACU and surgical ward. Modified Aldrete score assigns a score of 0, 1, or 2 to activity, respiration, circulation, consciousness, and color, giving a maximal score of 10 ( score of 9 indicates recovery sufficient for the patient to be transferred from the PACU). RSS [score 1-6] consists of six levels of sedation [Awake levels: 1, anxious and agitated or restless or both; 2, co-operative, orientated, and tranquil; 3,responds to commands only. Asleep levels are dependent on the response to a light glabellar tap or loud auditory stimulus: 4, a brisk response; 5, a sluggish response; 6, no response]. PONV ISS is the sum of the numerical responses to questions Q1 and Q2 ( Q1: The vomiting or dry-retching count? 0 - 2 or 3 (three or more times); Q2: Severity of nausea - interference with activities of daily living: score 0-3 [0 - not at all, 1-sometimes, 2- often or most of the time, 3 - all of the time] and score ≥5 defines clinically important PONV. Quality of Recovery questionnaire (QoR-40) on the first, second and third postoperative days will be used for assessment of postoperative quality of recovery.The QoR-40 consists of five clinically relevant dimensions: (i) physical comfort (12 items), (ii) emotional state (9 items), (iii) physical independence (5 items), (iv) psychological support (7 items), and (v) pain (7 items). Each item is rated on a five-point Likert scale. The QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). A 100 mm visual analogue scale (VAS) [0= no pain, 10= maximal pain] and the use of postoperative analgesics (opioids/non-opioids: yes or no, quantity in milligrams) shall be used for pain assessment during the first 24 postoperative hours.The sample size for early recovery time (primary endpoint) is based on the results of our recent study. The sample size was calculated on the assumption that 15 (SD 7) min would be needed for early recovery for the GO2 patients and that the GN2O patients would require four minutes less time (11 [SD 5] min). We would need 38 participants in each group for the primary outcome to have a power of 0.8 and an alpha level of 0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effects of Nitrous Oxide Added at the End of Sevoflurane Anesthesia on Recovery and Postoperative Nausea and Vomiting - a Randomized Clinical Trial (SEVONATE)
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrous oxide Group
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
The nitrous oxide group (GN2O) will receive 70% N2O in 30% O2 at the end of surgery.

No Intervention: Oxygen Group
The Oxygen group will receive gas carrier mixture consisting of air in 30% O2 during general anesthesia.



Primary Outcome Measures :
  1. Early recovery (awakening) in the operation room (OR) [ Time Frame: 15 minutes ]
    eye opening (in minutes), following verbal commands (in minutes), time to extubation (in minutes ), orientation to time and place (in minutes)


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    Simplified postoperative nausea and vomiting impact scale:the sum of the numerical responses to questions Q1 and Q2 ( Q1: The vomiting or dry-retching count? 0 -2 or 3 (three or more times); Q2: Severity of nausea - interference with activities of daily living: score 0-3 [0 - not at all, 1-sometimes, 2- often or most of the time, 3- all of the time] ) and score ≥5 defines clinically important PONV.

  2. Quality of recovery [ Time Frame: 72 hours ]
    Quality of Recovery 40 questionnaire on the first, second and third postoperative days: The QoR-40 consists of five clinically relevant dimensions: (i) physical comfort (12 items), (ii) emotional state (9 items), (iii) physical independence (5 items), (iv) psychological support (7 items), and (v) pain (7 items). Each item is rated on a five-point Likert scale. The QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

  3. Postoperative pain [ Time Frame: 24 hours ]
    Visual analogue scale VAS pain score [a 100 mm visual analogue scale (VAS) 0= no pain, 10= maximal pain]


Other Outcome Measures:
  1. Postoperative sedation [ Time Frame: 2 hours ]
    Ramsay Sedation Scale [score 1-6] consists of six levels of sedation [Awake levels: 1, patient anxious and agitated or restless or both; 2, patient co-operative, orientated, and tranquil; 3, patient responds to commands only. Asleep levels are dependent on the patient's response to a light glabellar tap or loud auditory stimulus: 4, a brisk response; 5, a sluggish response; and 6, no response].

  2. Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    The use of rescue antiemetics (yes/no and quantity in milligrams)

  3. Postoperative pain [ Time Frame: 24 hours ]
    The use of analgesics (opioids/nonopioids:yes/no and quantity in milligrams)

  4. Readiness for Discharge from the Postanesthesia Care Unit (PACU) [ Time Frame: 2 hours ]
    Modified Aldrete score: Activity - able to move voluntarily or on command: 2 - four extremities ; 1- two extremities ; 0- extremities 0; Respiration: 2 - able to deep breathe and cough freely , 1 - dyspnea, shallow or limited breathing , 0 - apneic. Circulation - blood pressure , BP of preanesthetic level: 2 - BP ± 20 mm; 1 - BP ± 20-50 mm; 0 - BP ± 50 mm. Consciousness: 2 fully awake;1 arousable on calling; 0 not responding.O2 saturation : 2 - able to maintain O2 saturation >92% on room air; 1- needs O2 inhalation to maintain O2 saturation >90%; 0 - O2 saturation <90% even with O2 supplementation. A score 9 and more = Ready for Discharge from the Postanesthesia Care Unit



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420586


Contacts
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Contact: Tatjana Simurina, MD, PhD +385 23 505 290 tsimurina@unizd.hr
Contact: Morana Ivancevic, MEE +385 23 213 777 morana@zadar.net

Locations
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Croatia
General Hospital Zadar Recruiting
Zadar, Croatia, 23000
Contact: Julija Šerić, MD    00385915384880    juli.seric@gmail.com   
Contact: Tatjana Simurina, MD, PhD    0038598331865    tatjana.simurina@gmail.com   
Principal Investigator: Tatjana Simurina, MD,PhD         
Sponsors and Collaborators
General Hospital Zadar
Investigators
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Principal Investigator: 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

Publications:

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Responsible Party: General Hospital Zadar
ClinicalTrials.gov Identifier: NCT03420586     History of Changes
Other Study ID Numbers: 01-5623-7/17
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by General Hospital Zadar:
Anesthetics, Inhalation
Anesthesia Recovery Period
Postoperative Nausea and Vomiting
Pain, Postoperative

Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Nausea
Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Anesthetics
Sevoflurane
Nitrous Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents