Effect of postoperative application of esketamine on postoperative depression and postoperative analgesia in patients undergoing pancreatoduodenectomy: a randomized controlled trial protocol.
Kaili Yu, Zhenguo Song, Bowen Zhang, Qian Pan, Shan Gan, Shaoyong Yang, Quanyong Yang, Xinhua Zuo, Yiqing Yin
Trials August 19, 2023 DOI: 10.1186/s13063-023-07575-8 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Sample size | 80 |
| Population | Patients undergoing elective pancreatoduodenectomy |
| Interventions | Esketamine Sufentanil |
| Dose | Esketamine 1.5 mg/kg + sufentanil 2 µg/kg diluted to 150 mL; control group sufentanil 2 µg/kg |
| Duration | 72-hour continuous infusion; follow-up to 12 months post-surgery |
| Measures | Hamilton Depression Scale (HAMD-17), visual analog scale (VAS), Richmond Agitation-Sedation Scale (RASS) |
| Topics | Esketamine Depression |
| Keywords | Pancreatoduodenectomy Postoperative analgesia Postoperative depression |
| Key findings | The protocol proposes that, compared with sufentanil alone, postoperative esketamine plus sufentanil will yield lower HAMD-17 and VAS scores, fewer adverse reactions, and lower serum concentrations of BDNP, 5-HT, TNF-α, and IL-6 after pancreatoduodenectomy. No outcome data are reported; the trial is planned with 80 patients. |
Abstract
Pancreatoduodenectomy (PD) is traumatic, difficult to perform, and has a high incidence of postoperative complications and perioperative mortality. Postoperative complications and pain occur frequently and seriously affect the psychological status of patients. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic and antidepressant effects. In this study, we aim to investigate the effect of esketamine on postoperative depression and pain in patients undergoing PD. This prospective, single-center, randomized control trial will include 80 patients who will undergo elective PD. The patients will be randomly assigned to two groups: the experimental group that will receive esketamine (n = 40) and the control group (n = 40). In the esketamine group, the analgesic pump will be connected immediately after surgery. A solution of esketamine 1.5 mg/kg + sufentanil 2 µg/kg, diluted to 150 mL, will be administered continuously for 72 h at the background infusion and impact doses of 1 mL/h and 2 mL/time, respectively; the locking time will be 10 min. The control group will receive sufentanil 2 µg/kg that will be administered as per the esketamine group. The primary outcome will be the Hamilton Depression Scale (HAMD-17) score on the third day post-surgery (POD3). Secondary study indicators will include (1) visual analog scale (VAS) score and HAMD-17 score prior to surgery, immediately after entering the postanesthesia care unit (PACU) and 1, 2, 3, 4, and 5 days after surgery; (2) Richmond Agitation-Sedation Scale (RASS) score at 1, 2, 3, 4, and 5 days after surgery; (3) consumed doses of sufentanil and esketamine after surgery; (4) postoperative analgesia pump effective press times, rescue analgesia times, and rescue drug dosage, recording the number of rescue analgesia and rescue drug dosage at 6, 24, 48, and 72 h after the patient enters the PACU; (5) postoperative complications and adverse events; (6) postoperative hospital stay; (7) concentrations of brain-derived neurotrophic factor (BDNP), 5-hydroxytryptamine (5-HT), tumor necrosis factor (TNF-α) and interleukin-6, at 1, 3, and, 5 days post-surgery; and (8) the patient survival rate at 6 and 12 months post-surgery. The study hypothesis is that the postoperative HAMD-17 and VAS scores, incidence of postoperative adverse reactions, and concentration of serum markers BDNP, 5-HT, TNF-α, and IL-6 in the experimental group will be lower than those in the control group. ClinicalTrials.gov ChiCTR2200066303. Registered on November 30, 2022. 1.0.
Comparable studies
Other randomized controlled trials on esketamine for depression, most cited first.