The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
-patients undergoing open gastrectomy for gastric cancer
Exclusion Criteria:
- American Society of Anesthesiology grade 3 or higher
- history of chemotherapy
- diagosis of cancer in other organs
- history of drug allergy
- weight less than 60kg
- BMI over 30 kg/m2 patient
- cognitive impairment
- gait disturbance
Sites / Locations
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexmedetomidine
Remifentanil
Arm Description
IV,0.2~0.8 µg/kg/hr
IV,0.05~0.2 µg/kg/min
Outcomes
Primary Outcome Measures
postoperative recovery time
number of days satisfying all following criteria 1)intestinal gas passage 2) tolerance of soft bland diet (SBD) for 24 hr. 3) safe ambulation without assistance 4) no requirement iv analgesics after discontinuation of PCA (VAS <4). 5) no abnormal physical signs or laboratory test.
Secondary Outcome Measures
maximum pain score
Visual analogue scale (VAS: 0-10)
post-operative hospital stay
days
complications and readmission rate at 3 months F/U time
incidence
post-operative period analgesic requirement
number of analgesic requirement despite intravenous patient controlled analgesia
opioid related side effect.
incidence of nausea, vomiting and pruritus
Full Information
NCT ID
NCT04529135
First Posted
August 11, 2020
Last Updated
June 22, 2022
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04529135
Brief Title
The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy
Official Title
The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
"Want to know the effect of dexmedetomidine during opioid free anesthesia on postoperative recovery after gastrectomy. Patients undergoing open gastrectomy are divided into dexmedetomidine group and control(remifentanil) group, administered during surgery, and compared with the speed of postoperative intestinal function recovery. Based on our institution's previous record, the average recovery time was 6 ± 1.4 days. Given that it is clinically significant to reduce recovery time by 20%, Alpha 0.05 and Power 80% require 31 samples per group, and assuming a 10% dropout rate, the total number of samples needed is 68.Subjects are patients aged 19 to 75 who are subject to open gastretomy planned by a gastric cancer. The exclusion criteria include American Society of Anesthesiology grade 3 or higher, patients who have previously been treated for cancer, patients with cancer other than the stomach, patients with drug allergies, weight less than 60kg, BMI > 30 kg/m2, patients who are unable to communicate and are unable to read consent (e.g., illiteracy, foreigners, etc.). The research method is a Randomized double-blind controlled study, and the assignment of both drugs is unknown and is used to maintain anesthesia in the form of continuous injection during surgery. Primary outcome is the recovery period satisfying the following. 1)intestinal gas passage 2) tolerance of soft bland diet (SBD) for 24 hr. 3) safe ambulation without assistance 4) no requirement iv analgesics after discontinuation of PCA (VAS <4). 5) no abnormal physical signs or laboratory test. The secondary outcomes are maximum VAS, post-operative hospital stay, complications and readmission rate at 3 months F/U time, post-operative period analgesic requirement, incidence of opioid related side effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double-blind Controlled Study
Masking
ParticipantCare ProviderInvestigator
Masking Description
Patients are divided into the Dexmedetomidine group / control group by random assignment. Using a table of computer-generated random numbers(s), assign 68 people to each county by 34 people. Random tables, in turn, seal the results in an opaque envelope. An anesthesiologist who is unaware of the content of this study and does not participate in the study receives information only about drug administration and is in charge of anesthesia, and does not disclose information about the assigned group to postoperative observers. Also, they don't disclose information about the assigned group to the surgeon.
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
IV,0.2~0.8 µg/kg/hr
Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
IV,0.05~0.2 µg/kg/min
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
The prepared drug marks the assigned group as unknown. In both groups, the test drug marked as unknown begins to be administered in an anesthetic induction. When the patient arrives in the operating room, electrocardiogram, noninvasive blood pressure, and bispectral index (BIS) monitoring is performed. In both groups, 2 mg/kg of propofol induces general anesthesia, intubates after administration of rocuronium 0.6 mg/kg, and maintains anesthesia with sevoflurane 1.5-2.5 vol%. Use 0.075 mg of palonosetrone as an antiemetics after inducing anesthesia. Adjust the inhalation anesthetic to maintain BIS 40-60 , mechanical ventilation to maintain the Tidal volume of 8 ml/kg, PEEP 5 mmHg and end-tidal carbon dioxide (EtCO2) of 35-40 mmHg. Push 1mcg of fentanyl and 1g of acetaminophen per kg for pain control 20 minutes before the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
The prepared drug marks the assigned group as unknown. In both groups, the test drug marked as unknown begins to be administered in an anesthetic induction. When the patient arrives in the operating room, electrocardiogram, noninvasive blood pressure, and bispectral index (BIS) monitoring is performed. In both groups, 2 mg/kg of propofol induces general anesthesia, intubates after administration of rocuronium 0.6 mg/kg, and maintains anesthesia with sevoflurane 1.5-2.5 vol%. Use 0.075 mg of palonosetrone as an antiemetics after inducing anesthesia. Adjust the inhalation anesthetic to maintain BIS 40-60 , mechanical ventilation to maintain the Tidal volume of 8 ml/kg, PEEP 5 mmHg and end-tidal carbon dioxide (EtCO2) of 35-40 mmHg. Push 1mcg of fentanyl and 1g of acetaminophen per kg for pain control 20 minutes before the end of surgery.
Primary Outcome Measure Information:
Title
postoperative recovery time
Description
number of days satisfying all following criteria 1)intestinal gas passage 2) tolerance of soft bland diet (SBD) for 24 hr. 3) safe ambulation without assistance 4) no requirement iv analgesics after discontinuation of PCA (VAS <4). 5) no abnormal physical signs or laboratory test.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
maximum pain score
Description
Visual analogue scale (VAS: 0-10)
Time Frame
3 months
Title
post-operative hospital stay
Description
days
Time Frame
3 months
Title
complications and readmission rate at 3 months F/U time
Description
incidence
Time Frame
3 months
Title
post-operative period analgesic requirement
Description
number of analgesic requirement despite intravenous patient controlled analgesia
Time Frame
3 months
Title
opioid related side effect.
Description
incidence of nausea, vomiting and pruritus
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-patients undergoing open gastrectomy for gastric cancer
Exclusion Criteria:
American Society of Anesthesiology grade 3 or higher
history of chemotherapy
diagosis of cancer in other organs
history of drug allergy
weight less than 60kg
BMI over 30 kg/m2 patient
cognitive impairment
gait disturbance
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy
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