The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy

Gastric Cancer Clinical Trial

Official title:

The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529135
• Other study ID #: 2020-0219-002
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: June 2022
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Dexmedetomidine
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.
• Remifentanil
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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	maximum pain score	Visual analogue scale (VAS: 0-10)	3 months
Secondary	post-operative hospital stay	days	3 months
Secondary	complications and readmission rate at 3 months F/U time	incidence	3 months
Secondary	post-operative period analgesic requirement	number of analgesic requirement despite intravenous patient controlled analgesia	3 months
Secondary	opioid related side effect.	incidence of nausea, vomiting and pruritus	3 months