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临床试验/NCT04657913
NCT04657913Unknown不适用

The Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery: A Randomized Controlled Study

Ankara Medipol University2 个研究点 分布在 2 个国家目标入组 108 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
108
试验地点
2
主要终点
mouth dryness severity

研究概览

简要总结

The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. This research was conducted as a randomized controlled trial.

详细描述

The study sample includes patients who had undergone major abdominal surgery induced by upper or lower gastrointestinal system malignancies. The patients who met the inclusion criteria were informed about the purpose of the study and were invited to the study. Those who accepted to participate in the study were included in the study.

Patients who had undergone major abdominal surgery with general anesthesia (induced by upper or lower gastrointestinal system malignancies), who do not have any oral and nasal diseases, who do not have visual, hearing, speech and understanding problems, who were in the American Society of Anesthesiologists (ASA) I and II grades, who were aged 18 or over and agreed to participate in the study were included.

Patients whose mouth and tongue mucosa integrity was degraded, who had a cognitive disorder, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results, or who use psychoactive drugs were excluded.

The standard anesthesia protocol was implemented to all patients suitable for the study. In the postoperative period, the standard rational dose antibiotic therapy (1st generation cephalosporin + metronidazole), metoclopramide HCL, NSAIDs, LMWH, N-acetylcysteine (NAC), H2-receptor blockers (ranitidine HCL), pethidine HCL 50 mg/ml, when required, and maintenance fluid therapy (Combination of normal saline, lactated Ringer's and Dextrose) by their weight were administered to the patients.

First Control Group: No intervention was performed on the patients in the control group. To prevent ethical violations, patients received routine clinical practice (a small amount of water was administered orally, using a syringe).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who underwent major abdominal surgery under general anesthesia (due to lower and upper gastrointestinal tract malignancy)
  • patients without oral and nasal disease
  • patients who do not have vision, hearing, speech and understanding problems
  • patients with American Society of Anesthesiologists (ASA) I and II scores
  • patients over the age of 18

排除标准

  • patients whose mouth and tongue mucosa integrity was degraded
  • patients had a cognitive disorder
  • patients had a neurological, renal, cardiac or pulmonary disorders that could affect the test results
  • patients using psychoactive drugs

结局指标

主要结局

mouth dryness severity

时间窗: Evaluation was made in the first 48 hours after surgery

Numbered between 0-10 0: no dry mouth 10: very severe dry mouth Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.

oral condition

时间窗: Evaluation was made in the first 48 hours after surgery

The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.

thirst severity

时间窗: Evaluation was made in the first 48 hours after surgery

Numbered between 0-10 0: no thirsty 10: very severe thirsty Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.

saliva PH

时间窗: Evaluation was made in the first 48 hours after surgery

To measure the pH value, the patient's saliva sample were taken and simple PH test sticks were used and the PH value were determined according to the color changes on the PH test stick.

次要结局

  • patient satisfaction assessed by the VAS(It were evaluated at 48th hours postoperatively.)

研究者

发起方
Ankara Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bediye Oztas

Principal investigator

Ankara Medipol University

研究点 (2)

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