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The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04021264
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bowel Disease Liver Diseases Pancreas Disease Anesthesia; Functional Drug: Ropivacaine-Sufentanil Drug: Dextrose 5 Phase 2 Phase 3

Detailed Description:

Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:

Epidural catheter insertion with 14 mL of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil injection (Treatment group) Epidural catheter insertion with 14 mL normal saline injection (Sham group) The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. After randomization, each patient will receive a clear 20 mL syringe containing either the Treatment or the Sham solution. Prior to induction of general anesthesia, an epidural catheter will be inserted by an experienced acute pain physician who has been performing epidural blocks for at least 5 years. Catheter placement will be verified by a single test dose of 60 mg lidocaine to exclude subarachnoid tip location.

Induction of general anesthesia will follow a standardized protocol with the intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) at if the PSI is <50 and the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. The epidural catheter will be run continuously throughout the surgery with 4-6 ml/h with study drug number 1 as per randomization - so either treatment or sham. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.

Postoperatively, patients will be transported to PACU where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU in both groups. The NRS for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blinded, randomized controlled, prospective
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sufentanil

Arm Intervention/treatment
Active Comparator: PRE-GA
14 mL injection of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil before the start of surgery and 14 ml of 5% dextrose at the end of surgery into the epidural catheter
Drug: Ropivacaine-Sufentanil
Local anesthetic injection

Drug: Dextrose 5
Sham injection

Sham Comparator: POST-GA
14 mL injection of 5% dextrose before the start of surgery and 14 ml of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil at the end of surgery into the epidural catheter
Drug: Ropivacaine-Sufentanil
Local anesthetic injection

Drug: Dextrose 5
Sham injection




Primary Outcome Measures :
  1. Average age-adjusted MAC of sevoflurane [ Time Frame: Intraoperative measurement done at the end of anesthetic ]
    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.


Secondary Outcome Measures :
  1. Intraoperative heart rate [ Time Frame: Intraoperative measurement ]
    Intraoperative heart rate (in beats/minute) will be documented at 5 minute interval and compared between the two groups

  2. Intraoperative opioid use [ Time Frame: Intraoperative measurement ]
    Intraoperative use of short acting opioid (in microgram/Kg) as per the study protocol will be recorded and compared between the two groups

  3. Postoperative opioid use in PACU [ Time Frame: Up to 24 postoperative hours ]
    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

  4. Maximum pain scores in the first 24 post-operative hours [ Time Frame: Up to 24 postoperative 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

  5. Nausea and vomiting in the first 24 post-operative hours [ Time Frame: Up to 24 postoperative 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

  6. 24 hour opioid consumption [ Time Frame: Up to 24 postoperative hours ]
    Frequency and total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups

  7. The sedation score in PACU [ Time Frame: 1st postoperative hour ]
    Sedation scores will be recorded at 15 minute intervals based on Ramsay sedation scale (1-6) and will be compared between the two groups

  8. Temperature testing ("Cold test") [ Time Frame: 1st postoperative hour ]
    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

  9. Intraoperative vasopressor usage [ Time Frame: Intraoperative period ]
    Amount and frequency of the intraoperative usage of vasopressor (phenylephrine in micrograms) will be documented and compared between the two groups

  10. Intraoperative mean blood pressure [ Time Frame: Intraoperative period ]
    Intraoperative mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All gender identification and self-representation is eligible
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021264


Contacts
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Contact: Timur JP Özelsel, MD, DESA 780-407-8861 ozelsel@ualberta.ca
Contact: Rakesh V Sondekoppam, MD 780-407-8861 rakesh6282@gmail.com

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G2G3
Contact: Timur JP Özelsel, MD    780-407-8861    ozelsel@ualberta.ca   
Contact: Rakesh V Sondekoppam, MD    780-407-8861    rakesh6282@gmail.com   
Principal Investigator: Timur JP Özelsel, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Study Director: Vivian HY Ip, MD University of Alberta
Study Director: Lora Pencheva, MD University of Alberta
Study Chair: Rakesh V Sondekoppam, MD University of Alberta
Principal Investigator: Timur JP Özelsel, MD, DESA University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04021264    
Other Study ID Numbers: Pro00092898
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Major abdominal surgery
epidural
environmental footprint
Additional relevant MeSH terms:
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Liver Diseases
Pancreatic Diseases
Digestive System Diseases
Sufentanil
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General