Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

Breast Cancer Clinical Trial

Official title:

Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736604
• Other study ID #: project number 1650
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: April 25, 2017
• Start date: May 2016
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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