Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

NCT02736604 | Completed DMC

• 1 other identifier: project number 1650
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• measurement of pain score and analgesic requirements

  up to 24 hours after surgery

• Airway device cuff pressures

  During the surgery

Study Arms (2)

Air anesthesia

EXPERIMENTAL

air will be used as carrier agent for maintenance of anesthesia

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

Nitrous Oxide anesthesia

ACTIVE COMPARATOR

nitrous oxide will be used as carrier agent for maintenance of anesthesia

Drug: nitrous oxide anesthesia; Device: laryngeal mask airway (LMA Supreme Size 3/4; Drug: sevoflurane

Interventions

nitrous oxide anesthesia DRUG

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

Nitrous Oxide anesthesia

air anesthesia DRUG

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

Air anesthesia

laryngeal mask airway (LMA Supreme Size 3/4 DEVICE

Air anesthesia; Nitrous Oxide anesthesia

sevoflurane DRUG

Air anesthesia; Nitrous Oxide anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Laryngeal Masks; Sevoflurane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• vijaya p patil, MD

  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, parel, mumbai, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and Anaesthetist

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 13, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)