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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04144933
Other study ID # BIO-625
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 15, 2021
Est. completion date August 1, 2024

Study information

Verified date December 2023
Source University of Saskatchewan
Contact Jonathan Gamble, MD
Phone 306-655-1183
Email jonathan.gamble@saskhealthauthority.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.


Description:

The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 1, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery Exclusion Criteria: - Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age < 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)

Study Design


Intervention

Drug:
Acetaminophen, Gabapentin
975 mg, 300 mg
Acetaminophen, Gabapentin
975 mg, 300 mg
Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine
1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
Dexamethasone, Ondansetron
6 mg, 4 mg
Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate
Dose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes
Lidocaine 1% Injectable Solution, Sufentanil
0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
Sevoflurane, Sufentanil
Dose titrated to effect, As needed (dose at anesthesiologist's discretion)

Locations

Country Name City State
Canada Royal University Hospital Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first flatus Time between the end of surgery and the movement when the patient first passes flatus End of surgery to first flatus (1-4 days)
Secondary Time to first defecation Time between the end of surgery and the moment the patient first passes stool End of surgery to first defecation (1-7 days)
Secondary Time to tolerance of oral intake Time between the end of surgery to when the patient can tolerate any oral solid food intake End of surgery to first oral intake (1-3 days)
Secondary Total Post-Anesthetic Care Unit (PACU) opioid consumption Total amount of opioid (morphine equivalents) required in PACU End of surgery to discharge from PACU (1-2 hours)
Secondary Patient Controlled Analgesia (PCA) morphine consumption Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively End of surgery to 48 hours postoperatively
Secondary Time to Post-Anesthetic Care Unit (PACU) discharge readiness Time to Post-Anesthetic Care Unit (PACU) discharge readiness End of surgery to PACU discharge readiness (1-3 hours)
Secondary Visual Analogue Scale (VAS) pain scores Visual Analogue Scale (VAS) pain scores will be recorded on a scale of 0 to 10, with 0 indicating no pain, and 10 indicating extreme pain, 48 hours following surgery End of surgery to 48 hours postoperatively
Secondary Quality of recovery after surgery Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery End of surgery to time of patient discharge from hospital (2-10 days)
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