Breast CancerNCT02736604
Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries
A study testing nitrous oxide anesthesia, air anesthesia and laryngeal mask airway (LMA Supreme Size 3/4 in people with Breast Cancer, run by Tata Memorial Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nitrous oxide anesthesia, air anesthesia and laryngeal mask airway (LMA Supreme Size 3/4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- May 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ASA I and II female patients aged 18 years or over posted for Breast Surgeries under General Anesthesia in the main operating rooms
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- nitrous oxide anesthesia, air anesthesia, laryngeal mask airway (LMA Supreme Size 3/4, sevoflurane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrous oxide anesthesiaDrug
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 anesthesiaDrug
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 3/4Device
sevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Air anesthesia | Experimental | air will be used as carrier agent for maintenance of anesthesia Receives: Drug: air anesthesia; Device: laryngeal mask airway (LMA Supreme Size 3/4; Drug: sevoflurane |
| Nitrous Oxide anesthesia | Active comparator | nitrous oxide will be used as carrier agent for maintenance of anesthesia Receives: Drug: nitrous oxide anesthesia; Device: laryngeal mask airway (LMA Supreme Size 3/4; Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours after surgery
Secondary outcomes (2)
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.
Measured: up to 24 hours after surgery
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
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vijaya P Patil, Tata Memorial Hospital
- Investigators
- vijaya p patil, MD, Principal investigator, Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, parel, mumbai, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736604
- Sponsor's protocol ID
- project number 1650
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries
- ClinicalTrials.gov ID
- NCT02736604
- Acronym / sponsor ID
- project number 1650
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air anesthesia | Experimental | Drug: air anesthesia, Device: laryngeal mask airway (LMA Supreme Size 3/4, Drug: sevofluraneair will be used as carrier agent for maintenance of anesthesia |
| Nitrous Oxide anesthesia | Active comparator | Drug: nitrous oxide anesthesia, Device: laryngeal mask airway (LMA Supreme Size 3/4, Drug: sevofluranenitrous oxide will be used as carrier agent for maintenance of anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. ASA I and II female patients aged 18 years or over posted for Breast Surgeries under General Anesthesia in the main operating rooms
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrous oxide anesthesiaGeneral 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 | Drug | Nitrous Oxide anesthesia |
| air anesthesiaGeneral 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 | Drug | Air anesthesia |
| laryngeal mask airway (LMA Supreme Size 3/4 | Device | Air anesthesia, Nitrous Oxide anesthesia |
| sevoflurane | Drug | Air anesthesia, Nitrous Oxide anesthesia |
Primary outcome
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.
2 secondary outcomes
measurement of pain score and analgesic requirements
Time frame: up to 24 hours after surgery
Airway device cuff pressures
Time frame: During the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
vijaya p patil, MD principal investigator
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, parel, mumbai, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitrous oxide anesthesia, air anesthesia and laryngeal mask airway (LMA Supreme Size 3/4 in people with Breast Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and severity of post operative nausea and vomiting (time frame: up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.