Effect of high-dose methylprednisolone on the early postoperative quality of recovery in patients undergoing minimally invasive esophagectomy: a randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080486

Enrollment

Unknown

Registered

2024-01-30

Start date

2024-02-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Methandrostenolone group:Intravenous methylprednisolone 120 mg before skin incision

Control group:An equal volume of saline was administered intravenously prior to skin incision

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) patients undergoing elective minimally invasive esophageal surgery (McKeown) under general anesthesia; (2) age = 18 years; (3) ASA classification I-III; and (4) signed informed consent form

Exclusion criteria

Exclusion criteria: (1) patients allergic to adrenocorticotropic hormone analogs; (2) patients taking glucocorticoids for a long period of time prior to surgery; (3) patients with critical illnesses, including severe hepatic dysfunction (e.g., hepatic failure), chronic renal failure (glomerular filtration rate < 30 ml/min), cardiac failure (NYHA cardiac classification = class IV), hypertension grade III, and COPD grades III and IV ( GOLD classification); (4) patients with active peptic ulcers and gastrointestinal bleeding; (5) patients with diabetes mellitus; (6) patients after coronary stenting; (7) patients with the presence of uncontrolled infections; (8) patients with severe osteoporosis; and (9) patients with a history of psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
QoR - 15 score on postoperative day 2;	—

Secondary

Measure	Time frame
QoR - 15 scores on postoperative days 1, 3, 7 and 30;NRS scores at rest and during movement on postoperative days 1-3;Opioid consumption (converted to morphine equivalent dose);First time out of bed;Incidence of nausea and vomiting within 3 days postoperatively;Incidence of anastomotic fistula postoperatively;Incidence of incisional infection postoperatively;Incidence of pulmonary complications (PPCs) at 7 days postoperatively;Classification of surgical complications at 7 days postoperatively (using the Clavien-Dindo ) ;Length of hospitalization;DAH (days alive and at home) at 30 days postoperatively;All-cause mortality at 30 days postoperatively;	—

Measure

Time frame

QoR - 15 scores on postoperative days 1, 3, 7 and 30;NRS scores at rest and during movement on postoperative days 1-3;Opioid consumption (converted to morphine equivalent dose);First time out of bed;Incidence of nausea and vomiting within 3 days postoperatively;Incidence of anastomotic fistula postoperatively;Incidence of incisional infection postoperatively;Incidence of pulmonary complications (PPCs) at 7 days postoperatively;Classification of surgical complications at 7 days postoperatively (using the Clavien-Dindo ) ;Length of hospitalization;DAH (days alive and at home) at 30 days postoperatively;All-cause mortality at 30 days postoperatively;

—

Countries

China

Contacts

Public ContactYu Hai

West China Hospital, Sichuan University

yuhai@scu.edu.cn+86 189 8060 1548

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026