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
|Condition or disease||Intervention/treatment||Phase|
|Elective Surgical Procedures Laparoscopy Laparotomy Anesthesia, General Anesthesia Recovery Period||Drug: Nitrous Oxide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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.|
|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|
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.
- 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)
- 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.
- 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).
- 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]
- 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].
- Postoperative nausea and vomiting [ Time Frame: 24 hours ]The use of rescue antiemetics (yes/no and quantity in milligrams)
- Postoperative pain [ Time Frame: 24 hours ]The use of analgesics (opioids/nonopioids:yes/no and quantity in milligrams)
- 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
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
|Contact: Tatjana Simurina, MD, PhD||+385 23 505 firstname.lastname@example.org|
|Contact: Morana Ivancevic, MEE||+385 23 213 email@example.com|
|General Hospital Zadar||Recruiting|
|Zadar, Croatia, 23000|
|Contact: Julija Šerić, MD 00385915384880 firstname.lastname@example.org|
|Contact: Tatjana Simurina, MD, PhD 0038598331865 email@example.com|
|Principal Investigator: Tatjana Simurina, MD,PhD|
|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|