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

NCT04021264 | Withdrawn Phase 2

• 1 other identifier: Pro00092898
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Disease; Liver Diseases; Pancreas Disease; Anesthesia; Functional

Keywords

Major abdominal surgery; epidural; environmental footprint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Intraoperative heart rate

  Intraoperative measurement

• Intraoperative opioid use

  Intraoperative measurement

• Postoperative opioid use in PACU

  Up to 24 postoperative hours

• Maximum pain scores in the first 24 post-operative hours

  Up to 24 postoperative hours

• Nausea and vomiting in the first 24 post-operative hours

  Up to 24 postoperative hours

Study Arms (2)

PRE-GA

ACTIVE COMPARATOR

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; Drug: Dextrose 5

POST-GA

SHAM COMPARATOR

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; Drug: Dextrose 5

Interventions

Ropivacaine-Sufentanil DRUG

Local anesthetic injection

POST-GA; PRE-GA

Dextrose 5 DRUG

Sham injection

POST-GA; PRE-GA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All gender identification and self-representation is eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2G3, Canada

Location

MeSH Terms

Conditions

Intestinal Diseases; Liver Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Vivian HY Ip, MD

  University of Alberta

  STUDY DIRECTOR

• Lora Pencheva, MD

  University of Alberta

  STUDY DIRECTOR

• Rakesh V Sondekoppam, MD

  University of Alberta

  STUDY CHAIR

• Timur JP Özelsel, MD, DESA

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, randomized controlled, prospective

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 16, 2019
• Study Start: August 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CA (1)