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ERAS After Bariatric Surgery in Morbidly Obese

Seoul National University logo

Seoul National University

Status

Completed

Conditions

ERAS
Obesity

Treatments

Procedure: ERAS protocol

Study type

Observational

Funder types

Other

Identifiers

NCT04891822
SNU-SLEEVE

Details and patient eligibility

About

Recently, the number of bariatric surgery is increasing but ERAS (Enhanced Recovery After Surgery) protocol for bariatric surgery needs revision with evidence. So we investigated usefulness of ERAS protocol for bariatric surgery in morbidly obese patients.

Full description

Patients undergoing elective laparoscopic bariatric surgery are going to be recruited and divided into 2 groups: Group E will receive ERAS protocol, and Group C will receive standard perioperative care.

ERAS protocol comprises 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery, TIVA(Total intra-venous anesthesia), TAP(transversus abdominis plane) block and IV-PCA using NSAIDs after surgery, and resumption of oral intake 2 hour after surgery.

Conventional anesthesia is composed of 8 hours of fasting, inhalation anesthesia, IV-PCA using NSAIDs, and resumption oral intake 6 hour after surgery.

In both groups, gastric ultrasonography will be used to measure gastric volume before surgery.

Functional hospital stay will be recorded from the end of surgery until all discharge criteria had been met. Pain scores will be recorded at 30 minutes, 4 hours, and 24 hours after surgery. Also, nausea and vomiting, time to ambulation, will be documented. After the patients are discharged, their charts are going to be reviewed and their medical expenses will be documented.

Enrollment

54 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists grade 1 ~ 3
  • BMI(Body Mass Index) ≥30
  • Scheduled for elective laparoscopic bariatric surgery

Exclusion criteria

  • American Society of Anesthesiologists grade 4 or 5
  • History of abdominal surgery

Trial design

54 participants in 2 patient groups

E (ERAS protocol)
Description:
receive ERAS protocol 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery TIVA(Total intra-venous anesthesia) TAP(transversus abdominis plane) block IV-PCA using NSAIDs after surgery Resuming oral intake 2 hours after surgery.
Treatment:
Procedure: ERAS protocol
C (Control)
Description:
receive standard perioperative care 8 hours of fasting before surgery Inhalation anesthesia IV-PCA using NSAIDs Resuming oral intake 6 hours after surgery.

Trial contacts and locations

1

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Central trial contact

Bon Wook Koo, MD; Hun-Taek Lee, MD

Data sourced from clinicaltrials.gov

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