Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial.

BACKGROUND: Postoperative morbidity and mortality after cardiac surgery with cardiopulmonary bypass (CPB) remain high despite recent advances in both anesthesia and perioperative management. Among modifiable risk factors for postoperative complications, optimal arterial pressure during and after surgery has been under debate for years. Recent data suggest that optimizing arterial pressure to the baseline of the patient may improve outcomes. We hypothesize that optimizing the mean arterial pressure (MAP) to the baseline MAP of the patient during cardiac surgery with CPB and during the first 24 hours postoperatively may improve outcomes. STUDY DESIGN: The OPTIPAM trial (NCT05403697) will be a multicenter, randomized, open-label controlled trial testing the superiority of optimized MAP management as compared with a MAP of 65 mm Hg or more during both the intraoperative and postoperative periods in 1,100 patients scheduled for cardiac surgery with CPB. The primary composite end point is the occurrence of acute kidney injury, neurological complications including stroke or postoperative delirium, and death. The secondary end points are hospital and intensive care unit lengths of stay, Day 7 and Day 90 mortality, postoperative cognitive dysfunction on Day 7 and Day 90, and quality of life at Day 7 and Day 90. Two interim analyses will assess the safety of the intervention. CONCLUSION: The OPTIPAM trial will assess the effectiveness of an individualized target of mean arterial pressure in cardiac surgery with CPB in reducing postoperative morbidity. CLINICAL TRIAL REGISTRATION: NCT05403697.

Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial.

BACKGROUND: Adding a regional block to general anaesthesia can prevent postoperative pain and improve peripheral circulation. OBJECTIVE: To seek improved postoperative analgesia and care due to a long-acting combined femoral and sciatic nerve block in patients undergoing femoropopliteal bypass surgery. DESIGN: A randomised, double-blind, controlled trial. SETTING: Vascular surgery unit of a French university hospital. PATIENTS: Forty-four adults scheduled for bypass surgery under general anaesthesia. INTERVENTION: Patients were allocated to receive either an active nerve block with 20 ml of 0.375% levobupivacaine and clonidine 0.5 µg kg, or a simulated (sham) block only, but with local anaesthesia of the skin, before general anaesthesia. General anaesthesia was standardised with propofol, then sevoflurane and sufentanil adjusted according to clinical need. Postoperative analgesia was standardised with paracetamol 1 g every 6 h, and intravenous morphine, initially titrated in the postanaesthesia care unit and then patient-controlled. Oral analgesics were repeated up to day 3. MAIN OUTCOME MEASURES: The primary outcome was morphine consumption during the first 24 postoperative hours. In a subgroup of postoperative patients distal tissue oxygen saturation was recorded at the lateral side of the blocked calf. RESULTS: Patients in the active group received less intra-operative sufentanil (median dose 25 vs. 41 µg), needed less morphine during the first 24 h (15 vs. 27 mg) and 72 (20 vs. 35 mg) postoperative hours, than in the control group. They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment. Tolerance outcomes were also similar between groups. CONCLUSION: Combining the two regional blocks improves the quality of postoperative care in this frail population, probably by reducing the amount of peri-operative opioid. TRIAL REGISTRATION: ClinicalTrials.gov (ref. NCT01785693).