Breast Cancer
Conditions
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.
Interventions
DRUGnitrous 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
DRUGair 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
DEVICElaryngeal mask airway (LMA Supreme Size 3/4
DRUGsevoflurane
Sponsors
Tata Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence and severity of post operative nausea and vomiting | 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
| Measure | Time frame | Description |
|---|---|---|
| measurement of pain score and analgesic requirements | 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. |
| Airway device cuff pressures | During the surgery | airway device cuff pressure will be measured during the surgery either endotracheal tube or laryngeal mask airway which ever is applicable |
Countries
India
Outcome results
None listed