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Environmental hazards of human activity are a topic of present day world, global warming being one of the leading concerns. Gases that contribute to this are greenhouse gases. Nitrous oxide (N2O) is a greenhouse gas that is commonly used in medical practice, mostly confined to provision of anaesthesia during surgical procedures in the operation theatre. N2O is not a potent anesthetic, and is used as a carrier for volatile anesthetic during general anaesthesia. This is to reduce the use of volatile anesthetics and other analgesic drugs while maintaining adequate depth of anaesthesia and analgesia. The N2O gas that is used during general anaesthesia is scavenged and released into the atmosphere without any processing. In the atmosphere it stays and produces deleterious greenhouse effect primarily owing to its long lifetime of 114 years. In addition, it also causes depletion of ozone layer. The green house effect of gases is evaluated and compared with the use of carbon-di-oxide equivalents (CDE). When the effects are considered for 20 years it is termed CDE20.The efforts to reduce these harmful effects can be directed towards reduction/cessation of N2O use, or its post anesthetic processing. The long history of its use in clinical practice and benefits such as analgesia for various procedures; makes it difficult to be completely taken out of usage in the present day anaesthesia practice. Though processing of N2O after use during GA is possible, it's impractical because of cost efficiency. We therefore, have directed our focus on further reducing its consumption while being used for GA. Low- flow anaesthesia has been in practice for the same reason (i.e. to reduce the wastage of gases).
This study is aimed to reduce the N2O consumption even further by employing a novel 'streamed-in' technique of N2O administration during low-flow GA. Conventionally, N2O use is initiated during the initial high fresh gas flows (FGF) before shifting to low-flow ventilation. 'Streamed-in' N2O administration strategy employs initiation of N2O into FGF after the institution of low-flow anaesthesia. Hence, the participants are not exposed to an unconventional drug or a new route of its administration, but an alternate strategy to its conventional use. We aim to evaluate the novel technique of 'streamed-in' N2O during sevoflurane GA for its global warming effects (in terms of CDE20) and its clinical effects ( intraoperative general anaesthesia state, hemodynamic profile) and post operative effects( postoperative nausea vomiting -PONV, postoperative pain profile- numerical rating scale-NRS)
Earliest use of nitrous oxide (N2O) in medical practice dates back to 1884. It aimed at providing analgesia during surgical procedure. Over the years the N2O use for anaesthesia evolved with the knowledge that it has very low anesthetic potential and high minimum alveolar concentration (MAC =104%), and therefore it cannot be used as a sole anesthetic. This led to N2O being used a carrier gas only during inhalational vapor (sevoflurane, isoflurane, desflurane) anaesthesia. The N2O- vapor co-administration not only reduces inhaled vapor requirements but also offers continuous analgesia state during maintenance of anaesthesia. Studies show its use in sedation and analgesia for labor analgesia and other minor procedures especially in pediatric population, such as, venipuncture, venous cannulation, fracture reduction, lumbar puncture, acute pain etc. Further, the use of intraoperative N2O also reduces the incidence of patients developing chronic postoperative pain.
The use of N2O, with attendant application advantages come the disadvantages of having undesirable effect on the patient (diffusion hypoxia, PONV), the medical care provider (megaloblastic anemia, risk of spontaneous abortion, reduced fertility) and environment (global warming). N2O possesses greenhouse effect defined in terms of global warming potential (GWP) [20 year GWP and 100year GWP - 289 (GWP20) and 298 (GWP100), respectively] and 'ozone depleting' properties. The above stated effects in conjunction with long life-span of N2O (114 years) in the atmosphere is likely to lead to longstanding negative environmental impact if its use is not stopped/made more efficient. Therefore, there is an absolute need for using N2O more efficiently for reducing effects on the patients, the first to get exposed operative room personnel, and ambient environment at large.
Sevoflurane is an inhalational anesthetic with a sweet smell, fast onset, offset and a good safety profile. Sevoflurane is also a greenhouse gas. Its use in combination with N2O is in practice for the benefits discussed earlier.
Having been in medical use for over 150 years with its various benefits, the use of N2O cannot be expected to be abandoned in the near future. Though steps to reduce anesthetic gas usage with techniques such as low-flow anaesthesia (fresh gas flow-FGF\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional' - N2O carrier gas group | Active Comparator | Ventilation will be initiated with 2% Sevoflurane in O2-N2O (60 % FiO2) @3L/min to MAC 0.5. Once MAC reaches 0.5, the FGF will be decreased to 1.0L/min (Low flow) and allowed to reach MAC 1.0 before incision is allowed. At 20-minutes time point post induction if MAC 1.0 is not achieved at 2% sevoflurane then the sevoflurane vaporizer concentration will be adjusted to achieve MAC 1.0, before incision is allowed. Anaesthesia will be maintained at MAC 1.0 throughout. After surgery is over, the N2O - Sevoflurane will be stopped and FGF increased to 3.0L with 100% O2. |
|
| 'Streamed -in' N2O carrier gas group | Active Comparator | Ventilation will be initiated with 2% Sevoflurane in O2 -Air (60 % FiO2) @3.0L/min to achieve a MAC of 0.5. Then, the FGF will be decreased to 1.0 L (low flow) and N2O will be 'streamed-in' @ 40 %. When MAC 1.0 is reached incision will be allowed. At 20-minutes time point post induction if MAC 1.0 is not achieved at 2% sevoflurane then the sevoflurane vaporizer concentration will be adjusted to achieve MAC 1.0, before incision is allowed. Anaesthesia will be maintained at MAC 1.0 throughout. After surgery is over, the N2O - Sevoflurane will be stopped and FGF increased to 3.0L with 100% O2. |
|
| Non-N2O group | Active Comparator | Ventilation will be initiated with 2% Sevoflurane in O2-Air (60 % FiO2 @ 3.0L/min) till the time it reaches MAC 0.5. Once MAC 0.5 reached, the FGF is decreased to 1.0L (Low-flow). The incision is allowed when MAC 1.0 is achieved .At 20-minutes time point post induction if MAC 1.0 is not achieved at 2% sevoflurane then the sevoflurane vaporizer concentration will be adjusted to achieve MAC 1.0, before incision is allowed. Anaesthesia will be maintained at MAC 1.0 throughout. After surgery is over, the O2 - Sevoflurane will be stopped and FGF increased to 3.0L with 100% O2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous oxide | Drug | In conventional nitrous oxide carrier group 2% Sevoflurane in O2-N2O (60 % FiO2) @3L/min will be delivered to achieve MAC 0.5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carbon-di-oxide equivalent -20 years (CDE20) | Carbon-di-oxide equivalent -20 years of nitrous oxide & sevoflurane will be calculated using the formula Mass of Anaesthetic used *GWP20 (Global Warming Potential -20 years) | From start of anesthesia till 5- minutes post extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative End-tidal anaesthesia gas (ETAG) concentration | ETAG concentration of nitrous oxide, sevoflurane, oxygen, carbon dioxide will be recorded from the patient monitor | From start of anesthesia till 5- minutes post extubation |
| Intraoperative minimum alveolar concentration (MAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amitabh Dutta, MD, PGDHR | Sir Ganga Ram Hospital, New Delhi, INDIA | Study Chair |
| Nitin Sethi, DNB | Sir Ganga Ram Hospital, New Delhi, INDIA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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One hundred and two patients of either sex, and schedule for elective surgery under general anesthesia (GA) will be randomly divided into three groups of 34-each.
Group 1('Conventional' N2O carrier gas group) Ventilation will be initiated with 2% Sevoflurane in O2-N2O (60 % FiO2) @3L/min to MAC 0.5. Once MAC reaches 0.5, the FGF will be decreased to 1.0L/min.
Group 2 ('Streamed-in' N2O carrier gas group) Ventilation will be initiated with 2% Sevoflurane in O2 -Air (60 % FiO2) @3.0L/min to achieve a MAC of 0.5. Then, the FGF will be decreased to 1.0 L (low flow) and N2O will be 'streamed-in' @ 40 %.
Group 3 (Non-N2O group) Ventilation will be initiated with 2% Sevoflurane in O2-Air (60 % FiO2 @ 3.0L/min) till the time it reaches MAC 0.5. Once MAC 0.5 reached, the FGF is decreased to 1.0L (Low-flow).
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The patient will be blinded to the type of anesthesia intervention. The attending anesthesiologist will however not be blinded to the technique utilized to administer GA and recovery immediately after extubation inside the OR. The postoperative patient profile will be evaluated by an independent assessor blinded to the technique of GA.
|
| Nitrous oxide | Drug | In streamed-in nitrous oxide carrier group 2% Sevoflurane in O2 -Air (60 % FiO2) will be delivered @3.0L/min to achieve a MAC of 0.5. Then, the FGF will be decreased to 1.0 L (low flow) and N2O will be 'streamed-in' @ 40 %. |
|
| Sevoflurane | Drug | Ventilation will be initiated with 2% sevoflurane in all the groups |
|
MAC will be recorded from the patient monitor |
| From start of anesthesia till 5- minutes post extubation |
| Intraoperative consumption of anesthetic gases | Intraoperative consumption of nitrous oxide, sevoflurane, oxygen and air will be noted at the end of anesthesia from the log book of the anesthesia machine | From start of anesthesia till 5- minutes post extubation |
| Changes in intra-operative heart rate (beats per minute) | Comparison of intra-operative heart rate will be done among the three groups | From start of anesthesia till 5- minutes post extubation |
| Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) | Comparison of intra-operative blood pressure- systolic, diastolic, and mean will be done among the three groups | From start of anesthesia till 5- minutes post extubation |
| Changes in rate pressure product | Comparison of rate pressure product will be done among the three groups. Rate pressure product will be calculated using the formula :Systolic blood pressure *heart rate /1000 | From start of anesthesia till 5- minutes post extubation |
| Postoperative Nausea and Vomiting (PONV) | PONV will be assessed using postoperative nausea and vomiting (PONV) Scale. The scale measures PONV on a scale of 0 to 2. A score of '0' indicates that the patient has no emetic symptoms, whereas a score of '2' indicates that the patient has vomiting. | From end of anaesthesia till 24-hours postoperatively |
| Postoperative pain | Postoperative pain will be assessed using the 10-point numerical rating scale. The scale has scoring from 0 to 10. '0' implying minimum pain & '10' implying maximum pain | From end of anaesthesia till 24-hours postoperatively |
| Incidence of intraoperative awareness | Awareness will be assessed using 5-question based Brice Structured Interview | From end of anaesthesia till 24-hours postoperatively |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |