Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

NCT ID: NCT02736604

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Air anesthesia

air will be used as carrier agent for maintenance of anesthesia

Group Type: EXPERIMENTAL

air anesthesia

Intervention Type: 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

Intervention Type: DEVICE

sevoflurane

Intervention Type: DRUG

Nitrous Oxide anesthesia

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

Group Type: ACTIVE_COMPARATOR

nitrous oxide anesthesia

Intervention Type: 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

laryngeal mask airway (LMA Supreme Size 3/4

Intervention Type: DEVICE

sevoflurane

Intervention Type: DRUG

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

laryngeal mask airway (LMA Supreme Size 3/4

Intervention Type: DEVICE

sevoflurane

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vijaya P Patil

professor and Anaesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

vijaya p patil, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

project number 1650

Identifier Type: -

Identifier Source: org_study_id