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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400012
- Tata Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Air anesthesia
air will be used as carrier agent for maintenance of 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
|
|
Active Comparator: Nitrous Oxide anesthesia
nitrous oxide will be used as carrier agent for maintenance of 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
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.
|
up to 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 24 hours after surgery
|
|
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
|
During the surgery
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- project number 1650
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.