Preoperative Oral Carbohydrate Loading in Gynecologic Surgery

Eunah Cho, MD

Status: Completed

Conditions: Postoperative Recovery

Treatments: Dietary Supplement: NO-NPO (Daesang WelLife Co., Ltd., Korea)

Study type: Interventional

Funder types: Other

Identifiers

NCT03955419

KBSMC 2019-04-015-001

Details and patient eligibility

About

The advantage of carbohydrate loading in minimally invasive surgeries are not well established. We designed this study to evaluate whether preoperative oral carbohydrate improve postoperative recovery after laparoscopic gynecologic surgeries.

Full description

This study will be conducted in the female adult patient scheduled for laparoscopic gynecologic surgery for benign or premalignant condition. Patients with American Society of Anesthesiologist physical status classification I-II, not pregnant or on lactation will be included. Patients with underlying disease that will delay gastric emptying (GERD, history of gastrointestinal surgery, diabetes), or contraindicated to NSAID or opioid, psychiatric or mental disorders, alcoholism, or drug abuse will be excluded.

Participants will be randomized into 2 group: the control group and the study group. Randomization will be conducted via random block with stratification generated by the http://www.randomization.com with 1:1 allocation. The sequence will be kept in opaque, sealed envelopes until the day before the study date. One investigator, not involved in the outcome assessment, opened the envelope on the day before the surgery, and allocated participants in each group.

After having regular diet until the evening before surgery, participants allocate in the control group were kept fasted from midnight until surgery. Participants in the study group will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg). The participants in the study group will freely drink carbohydrate beverage starting from the evening before surgery up to 2 hours before surgery.

The postoperative quality of recovery (QoR) score, time to readiness to discharge, patient satisfaction, postoperative nausea and vomiting, change in body weight, and insulin resistance will be assessed.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

age between 18 and 70 years American Society of Anesthesiologists physical status (ASAPS) classification I-II absence of pregnancy or lactation at the time of surgery.

Exclusion criteria

suspicious delayed gastric emptying such as GERD or gastrointestinal surgery metabolic disorders such as diabetes known contraindications to NSAID or opioid physically disabled severe psychiatric or mental disorders alcoholism, drug abuse

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Control group

No Intervention group

Description:

Participants in the control group will be fasted from midnight until surgery.

Study group

Experimental group

Description:

Participants will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg). They will drink this beverage freely, starting from the evening before surgery until 2 hours before surgery.

Treatment:

Dietary Supplement: NO-NPO (Daesang WelLife Co., Ltd., Korea)