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Completed

NCT Number: NCT02736604

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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)

Treatment and study plan

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

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

laryngeal mask airway (LMA Supreme Size 3/4

Device

Sevoflurane

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 13, 2016
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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