Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.
Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC). RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. However, whether perioperative remote ischemic conditioning (PRIC) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Sham-Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.
Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, the morning of the postoperative day 1, the morning of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg. Sham-Remote Ischemic Conditioning (at the time points of 30 min after surgery, the afternoon of the postoperative day 1, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, China
Alanine aminotransferase (ALT)
The levels of ALT in perioperative period
Time frame: 7 days
Aspartate aminotransferase (AST)
The levels of AST in perioperative period
Time frame: 7 days
Total bilirubin (TBIL)
The levels of TBIL in perioperative period
Time frame: 7 days
International normalized ratio (INR)
The levels of INR in perioperative period
Time frame: 7 days
Albumin (ALB)
The levels of ALB in perioperative period
Time frame: 7 days
Tumor necrosis factor-α (TNF-α)
The levels of TNF-α in perioperative period
Time frame: 7 days
Malondialdehyde (MDA)
The levels of MDA in perioperative period
Time frame: 7 days
Heme oxygenase-1 (HO-1)
The levels of HO-1 in perioperative period
Time frame: 7 days
Nuclear Factor-κB (NF-κB)
The levels of NF-κB in perioperative period
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.
High mobility group box1 (HMGB1)
The levels of HMGB1 in perioperative period
Time frame: 7 days
Platelet
The levels of platelet in perioperative period
Time frame: 7 days
White blood cell (WBC)
The levels of WBC in perioperative period
Time frame: 7 days
Neutrophil granulocyte percentage
The levels of neutrophil granulocyte percentage in perioperative period
Time frame: 7 days
Time to gastrointestinal tolerance
Gastrointestinal tolerance was defined as transanal or stoma defecation and oral dietary tolerance.
Time frame: 7 days
Prolonged postoperative ileus
Prolonged postoperative ileus was diagnosed if patients met two or more of the following conditions on or after postoperative day 4: inability to tolerate the oral diet over the past 24 h, nausea or vomiting, without flatus over the past 24 h, abdominal distension or radiological evidence of intestinal distension without mechanical intestinal obstruction.
Time frame: 7 days
Rate of postoperative complications
The postoperative complications were recorded using the Clavien-Dindo classification system and included: nausea or vomiting, abdominal distension, anastomotic leakage, new pulmonary infection, poor wound healing, cognitive dysfunction, unplanned reoperation, and 30-day readmission rate.
Time frame: 30 days