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临床试验/CTRI/2025/08/093778
CTRI/2025/08/093778尚未招募2/3 期

EFFECT OF GUM CHEWING ON RESIDUAL GASTRIC VOLUME IN FASTED OBESE PATIENTS: A RANDOMIZED CONTROLLED TRIAL

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年9月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Residual gastric volume using USG (POCUS-G)

研究概览

简要总结

Patients will be randomized in one of the two groups i.e. Group CG where patients will chew a sugar free gum for one hour and Group NG where no gum will be chewed. All patients will be assessed for Baseline residual gastric volume using point-of-care gastric ultrasound (POCUS-G) (V0), Quality of Recovery-15 (QoR-15), Anxiety using Amsterdam peri-operative anxiety scale (APAIS) at the beginning of the study in the preoperative room as baseline. Thirst score and Hunger score will be recorded as baseline. Thereafter, they will be asked to chew a sugar-free gum for an hour. After one hour, the gum will be removed and residual gastric volume will be assessed at the end of 1st hr and then at the end of 2nd hr. After the second residual gastric volume assessment, anxiety assessment using APAIS will be done along with Thirst score and Hunger score before the patient is wheeled in the OT. In the postoperative period, PONV score at 1st, 4th, 6th, 12th and 24th hour, QoR-15 score at the end of day1 will be assessed.

The primary outcome will be residual gastric volume at the end of 1st hour. The secondary outcomes will be residual gastric volume at the end of 2nd hour,  APAIS Baseline and at 2nd hour of gum chewing, PONV score at the end of 1st, 4th, 6th and 12th and 24th hour post-operatively, Thirst score and Hunger score at baseline and at the end of 2nd hour,  QoR – 15 score at baseline and at day one  Sore throat and Hoarseness at day one**.**

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Consenting patients of either sex with BMI more than 30kg/m2 aged 18-60 years ASA I-III undergoing elective surgery.

排除标准

  • patients will if excluded if Pregnant or having diabetes mellitus trauma patients patients having recent upper gastrointestinal bleed previous gastric or lower esophageal surgery documented abnormalities of upper gastrointestinal tract such as hiatal hernia and gastric tumors.

结局指标

主要结局

Residual gastric volume using USG (POCUS-G)

时间窗: Residual gastric volume using USG (POCUS-G) at the end of one hour of gum chewing

次要结局

  • Residual gastric volume(APAIS)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Geetanjali T Chilkoti

UCMS & GTB Hospital

研究点 (1)

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