Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: air anesthesia; Device: laryngeal mask airway (LMA Supreme Size 3/4; Drug: sevoflurane; Drug: nitrous oxide anesthesia

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence and severity of post operative nausea and vomiting	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.	up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of pain score and analgesic requirements	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.	up to 24 hours after surgery
Airway device cuff pressures	airway device cuff pressure will be measured during the surgery either endotracheal tube or laryngeal mask airway which ever is applicable	During the surgery

Collaborators and Investigators

• Sponsor: Tata Memorial Hospital
• Investigators: Principal Investigator: vijaya p patil, MD, Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, parel, mumbai, India

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics; Sevoflurane; Nitrous Oxide
• Other Study ID Numbers: project number 1650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes