Liver Diseases Clinical Trial
Official title:
The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery
Verified date | May 2022 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Major abdominal surgery - like non-laparoscopic bowel resection, liver, gastric, or pancreas surgery - is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic. The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the epidural block is applied before or after surgery. Patients will have a nerve block catheter (epidural catheter) placed prior to the induction of general anesthetic by an experienced regional anesthesiologist. The epidural catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or dextrose (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a dextrose (sham) or local anesthetic before the patient is woken up.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing elective reconstructive foot and ankle surgery - Patients eligible for popliteal and saphenous nerve block - All adults 18 years of age or older - Capable to give consent Exclusion Criteria: - Patients who are unable to give consent - Local anaesthetic allergy - Hemidiaphragm paresis on the contralateral side to the block/surgery site - Bleeding diathesis - Coagulopathy - Pre-existing neurological deficits - Patients with a Body Mass Index >35 - Patients with significant comorbidities, physiological limitations, and allergies that are unable to tolerate the protocolized induction and maintenance of anesthesia. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average age-adjusted MAC of sevoflurane | The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups. | Intraoperative measurement done at the end of anesthetic | |
Secondary | Intraoperative heart rate | Intraoperative heart rate (in beats/minute) will be documented at 5 minute interval and compared between the two groups | Intraoperative measurement | |
Secondary | Intraoperative opioid use | Intraoperative use of short acting opioid (in microgram/Kg) as per the study protocol will be recorded and compared between the two groups | Intraoperative measurement | |
Secondary | Postoperative opioid use in PACU | Total amount of opioids (in mg of morphine equivalents) in the PACU and over the first 24 postoperative hours will be recorded and compared between the two groups | Up to 24 postoperative hours | |
Secondary | Maximum pain scores in the first 24 post-operative hours | Maximum pain scores will be recorded using numerical rating scale (NRS) of 0-10 (where 0=no pain and 10= maximum pain) on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and compared between the two groups | Up to 24 postoperative hours | |
Secondary | Nausea and vomiting in the first 24 post-operative hours | Nausea scores (on a Likert scale of 1-4 where 1 = no nausea, 2= mild nausea, 3= moderate nausea and 4= severe nausea) and incidence of vomiting will be recorded on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and will be compared between the two groups | Up to 24 postoperative hours | |
Secondary | 24 hour opioid consumption | Frequency and total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups | Up to 24 postoperative hours | |
Secondary | The sedation score in PACU | Sedation scores will be recorded at 15 minute intervals based on Ramsay sedation scale (1-6) and will be compared between the two groups | 1st postoperative hour | |
Secondary | Temperature testing ("Cold test") | Sensory testing of the abdominal dermatomes will be performed in the PACU at 30 minutes of arrival to PACU to document the success of the block | 1st postoperative hour | |
Secondary | Intraoperative vasopressor usage | Amount and frequency of the intraoperative usage of vasopressor (phenylephrine in micrograms) will be documented and compared between the two groups | Intraoperative period | |
Secondary | Intraoperative mean blood pressure | Intraoperative mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups | Intraoperative period |
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