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Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

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ClinicalTrials.gov Identifier: NCT02736604
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Vijaya P Patil, Tata Memorial Hospital

Brief Summary:

Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant postoperative discomforts and lead to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is associated with significant morbidity. It may also result in delayed discharge, which is particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more susceptible to PONV than men and breast surgery, which is primarily done in an outpatient setting, is associated with high incidence of PONV, ranging between 15% and 84% in the absence of prophylactic treatment.

Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms: (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has been demonstrated to increase the incidence of PONV in some studies but not in others. The present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia on the undesirable clinical outcome of PONV.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: nitrous oxide anesthesia Drug: air anesthesia Device: laryngeal mask airway (LMA Supreme Size 3/4 Drug: sevoflurane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries
Actual Study Start Date : May 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : February 2017

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Arm Intervention/treatment
Experimental: Air anesthesia
air will be used as carrier agent for maintenance of anesthesia
Drug: air anesthesia
General anesthesia will be maintained by 40% oxygen (FiO2 0.4) with air and volatile anesthetic sevoflurane through laryngeal mask airway (LMA Supreme Size 3/4) or endotracheal tube (Size 7.0-7.5). All patients will receive standard anesthetic care and monitoring

Device: laryngeal mask airway (LMA Supreme Size 3/4
Drug: sevoflurane
Active Comparator: Nitrous Oxide anesthesia
nitrous oxide will be used as carrier agent for maintenance of anesthesia
Drug: nitrous oxide anesthesia
General anesthesia will be maintained by 40% oxygen (FiO2 0.4) with Nitrous Oxide and volatile anesthetic sevoflurane through laryngeal mask airway (LMA Supreme Size 3/4) or endotracheal tube (Size 7.0-7.5). All patients will receive standard anesthetic care and monitoring

Device: laryngeal mask airway (LMA Supreme Size 3/4
Drug: sevoflurane



Primary Outcome Measures :
  1. incidence and severity of post operative nausea and vomiting [ Time Frame: up to 24 hours after surgery ]
    Patients will be followed for 24 hours post-surgery or discharge from hospital whichever is earlier. postoperative nausea and vomiting intensity scale will be used to assess incidence and severity of nausea and vomiting.


Secondary Outcome Measures :
  1. measurement of pain score and analgesic requirements [ Time Frame: up to 24 hours after surgery ]
    Patients will be followed for 24 hours post-surgery or discharge from hospital whichever is earlier. Pain score will be measured by Visual Analogue Scale from 0-10.

  2. Airway device cuff pressures [ Time Frame: During the surgery ]
    airway device cuff pressure will be measured during the surgery either endotracheal tube or laryngeal mask airway which ever is applicable



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. ASA I and II female patients aged 18 years or over posted for Breast Surgeries under General Anesthesia in the main operating rooms

Exclusion Criteria:

  1. ASA III, IV, V female patients
  2. Age less than 18 years
  3. Patients undergoing Breast Reconstructive Surgery
  4. Patients with contraindications to Fentanyl, Diclofenac, Paracetamol, Atracurium
  5. Chronic pain patients on long-term opioid medication
  6. Use of regional anesthetic technique (e.g. Paravertebral Block)

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): NCT02736604


Locations
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India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: vijaya p patil, MD Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, parel, mumbai, India

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Responsible Party: Vijaya P Patil, professor and Anaesthetist, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02736604     History of Changes
Other Study ID Numbers: project number 1650
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Nitrous Oxide
Anesthetics
Sevoflurane
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