Anesthesia, General, Anesthesia Recovery Period, Elective Surgical Procedures, Laparoscopy, Laparotomy
Conditions
Keywords
Anesthetics, Inhalation, Anesthesia Recovery Period, Postoperative Nausea and Vomiting, Pain, Postoperative
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.
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.
Interventions
DRUGNitrous Oxide
The nitrous oxide group (GN2O) will receive 70% N2O in 30% O2 at the end of surgery.
Sponsors
General Hospital Zadar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Intervention Model: Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early recovery (awakening) in the operation room (OR) | 15 minutes | eye opening (in minutes), following verbal commands (in minutes), time to extubation (in minutes ), orientation to time and place (in minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting | 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 | 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 | 24 hours | Visual analogue scale VAS pain score \[a 100 mm visual analogue scale (VAS) 0= no pain, 10= maximal pain\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative sedation | 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 | 24 hours | The use of rescue antiemetics (yes/no and quantity in milligrams) |
| Postoperative pain | 24 hours | The use of analgesics (opioids/nonopioids:yes/no and quantity in milligrams) |
| Readiness for Discharge from the Postanesthesia Care Unit (PACU) | 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 |
Countries
Croatia
Outcome results
None listed