Preoperative Oral Carbohydrate Loading in Gynecologic Surgery
Mots clés
Abstrait
La 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.
Rendez-vous
| Dernière vérification: | 04/30/2020 |
| Première soumission: | 05/15/2019 |
| Inscription estimée soumise: | 05/15/2019 |
| Première publication: | 05/19/2019 |
| Dernière mise à jour soumise: | 05/06/2020 |
| Dernière mise à jour publiée: | 05/10/2020 |
| Date de début réelle de l'étude: | 07/24/2019 |
| Date d'achèvement primaire estimée: | 03/29/2020 |
| Date estimée d'achèvement de l'étude: | 03/29/2020 |
Condition ou maladie
Intervention / traitement
Dietary Supplement: Study group
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| No Intervention: Control group Participants in the control group will be fasted from midnight until surgery. | |
| Experimental: Study group 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. | Dietary Supplement: Study group 800 mL of carbohydrate beverage consists of 12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg. |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | Female |
| Accepte les bénévoles en santé | Oui |
| Critères | 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 |
Résultat
Mesures des résultats primaires
1. Quality of recovery (QoR)-15 score [2 days after surgery]
Mesures des résultats secondaires
1. time to readiness to discharge (TRD) [2 days after surgery]
