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Global Warming Impact and Clinical Effects of a Novel 'streamed-in' Nitrous Oxide Administration as a Carrier Gas During Sevoflurane General Anaesthesia: a Randomized Pilot Study
Sponsor study identifier
interventional
102
1 country
1
Study Start
June 29, 2022
Actual (reported)Primary Completion
April 22, 2023
Actual (reported)Study Completion
April 22, 2023
Actual (reported)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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 22, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2022
Actual (reported)June 24, 2022
Actual (reported)June 29, 2022
Actual (reported)April 22, 2023
Actual (reported)April 22, 2023
Actual (reported)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
Intraoperative End-tidal anaesthesia gas (ETAG) concentration
From start of anesthesia till 5- minutes post extubation
Intraoperative minimum alveolar concentration (MAC)
From start of anesthesia till 5- minutes post extubation
Intraoperative consumption of anesthetic gases
From start of anesthesia till 5- minutes post extubation
Changes in intra-operative heart rate (beats per minute)
From start of anesthesia till 5- minutes post extubation
Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)
From start of anesthesia till 5- minutes post extubation
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.
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.
In conventional nitrous oxide carrier group 2% Sevoflurane in O2-N2O (60 % FiO2) @3L/min will be delivered to achieve MAC 0.5.
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 %.
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Amitabh Dutta, MD, PGDHR
Sir Ganga Ram Hospital, New Delhi, INDIA
Nitin Sethi, DNB
Sir Ganga Ram Hospital, New Delhi, INDIA
102 participants (actual enrollment reported by the registry).
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.
Ventilation will be initiated with 2% sevoflurane in all the groups
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First Submitted
June 18, 2022
First Posted
June 24, 2022
Study Start
June 29, 2022
Actual (reported)Primary Completion
April 22, 2023
Actual (reported)Study Completion
April 22, 2023
Actual (reported)Last Updated
August 9, 2023
Record last verified: 2023-08
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