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

• ClinicalTrials.gov Identifier: NCT04529135
• Recruitment Status: Recruiting
• First Posted: August 27, 2020
• Last Update Posted: June 18, 2021
• Sponsor: Gangnam Severance Hospital
• Information provided by (Responsible Party): Ji-young Kim, Gangnam Severance Hospital

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: Dexmedetomidine; Drug: Remifentanil	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Double-blind Controlled Study
• Masking: Triple (Participant, Care Provider, Investigator)
• 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.
• Primary Purpose: Treatment
• Official Title: The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy : A Randomized Controlled Trial
• Actual Study Start Date: August 26, 2020
• Estimated Primary Completion Date: August 11, 2021
• Estimated Study Completion Date: September 11, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dexmedetomidine; IV,0.2~0.8 µg/kg/hr	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.
Active Comparator: Remifentanil; IV,0.05~0.2 µg/kg/min	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. postoperative recovery time [ Time Frame: 3 months ]
   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 :

1. maximum pain score [ Time Frame: 3 months ]
   Visual analogue scale (VAS: 0-10)
2. post-operative hospital stay [ Time Frame: 3 months ]
   days
3. complications and readmission rate at 3 months F/U time [ Time Frame: 3 months ]
   incidence
4. post-operative period analgesic requirement [ Time Frame: 3 months ]
   number of analgesic requirement despite intravenous patient controlled analgesia
5. opioid related side effect. [ Time Frame: 3 months ]
   incidence of nausea, vomiting and pruritus

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Gangnam Severance Hospital; Recruiting

Seoul, Korea, Republic of, 06273

Contact: Ji Y Kim 82220193525 kimjy@yuhs.ac

Sponsors and Collaborators

Gangnam Severance Hospital

More Information

• Responsible Party: Ji-young Kim, Associate professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT04529135
• Other Study ID Numbers: 2020-0219-002
• First Posted: August 27, 2020
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Dexmedetomidine; Remifentanil; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics