Anesthesia and ThirstNCT05172648
Effect of Small-volume Oral Spray in the After Anesthesia Recovery Room for Thirst Patients
A study testing oral spry and Cotton swab in people with Anesthesia and Thirst, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Currently, there are limited studies performed on the treatment of perioperative thirst and the methods provided by literature possess a risk of choking. In addition, there is no good treatment nor relevant research in the area of perioperative thirst in Taiwan. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Anesthesia and Thirst
- What is being tested?
- oral spry and Cotton swab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2022to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VAS thirst assessment form score ≥ 4 points
- Age 20-75 years old
- Anesthesia risk assessment grade Amersican Society of Anesthesiologists: I~III:The first level (ASAⅠ)-healthy people, except for surgical corrections, without any systemic disease patients, such as patients with simple appendicitis (pre- and post-operative mortality rate 0.06~0.08%); Level 2 (ASAⅡ)-Patients with mild systemic disease but no functional impairment, such as those over 70 years old without any disease, or a small cold, HTN or DM but well-controlled diseases (pre- and post-operative mortality 0.27~0.4%); Level III (ASAⅢ)-Moderate to severe systemic disease and cause partial dysfunction, such as HTN or DM but not well controlled, or have cardiovascular complications (stroke, myocardial infarction, angina, etc.) (The mortality rate before and after surgery is 1.8~4.3%).
- Conscious (GCS: 15 points).
- Muscle power ≥ 4 points.
- Anesthesia recovery score Aldrate score ≥8 points: Consciousness: Fully awake, in full contact; Mobility: Able to move 2 extremities on command; Breathing: Able to breathe deeply and cough freely; Circulation: BP ±20-49% of pre-anesthetic level; Skin color: Normal.
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- Informed consent.
- Excluded Criteria:
- Those who underwent head and neck surgery this time or had a history of head and neck surgery: Acoustic immittance testing, Acoustic voice assessment, Aerodynamic voice assessment, Airway reconstruction, Auditory brainstem implant, Auditory evoked potential test, Aural rehabilitation, Balloon sinuplasty, Blepharoplasty, Botox injections, Bronchoscopy, Brow lift, Canalith repositioning procedure, Chemical peel, Cleft lip repair, Cleft palate repair, CO-2 laser treatment, Cochlear implants, Computerized dynamic posturography, Cosmetic surgery, Custom ear protector fitting, Dental implant surgery, Electroacoustic assessments of hearing aids, Electromyography (EMG), Electronystagmography, Endoscopic sinus surgery, Esophagoscopy, Face-lift, Facial fillers for wrinkles, Facial fracture repair, Facial nerve rehabilitation, Facial reconstruction, Facial rejuvenation, Fat grafting, Flexible endoscopic evaluation of swallowing with sensory, testing (FEESST), Hearing aid fitting, Hearing conservation services, Hearing implant surgery, Hearing monitoring services, Hearing test, Hearing test for children, Infant hearing screening, KTP laser treatment, Laryngeal reinnervation, Laryngoscopy, Laryngotracheal reconstruction, Larynx transplant, Laser resurfacing, Lip surgery, Mastoidectomy, Maxillomandibular advancement surgery, Microlaryngoscopy, Microvascular reconstruction, Middle ear reconstruction, Minimally invasive surgery, Nasal septal reconstruction, Nasal valve repair, Neck lift, Newborn hearing screening, Nose reconstruction, Otoacoustic emissions (OEA) test, Otological microsurgery, Otoplasty, Parathyroidectomy, Parotid gland surgery, Parotidectomy, Pharyngeal manometry, Professional voice evaluation, Rhinoplasty, Robotic surgery, Rotary-chair testing, Scar revision, Septoplasty, Singing voice evaluation, Sinus surgery, Skin cancer reconstruction, Speech-language pathology evaluation, Stapedectomy, Stroboscopy, Swallowing exercises, Swim mold fitting, Thyroid surgery, Thyroidectomy, Thyroplasty, Tinnitus assessment, Tonsillectomy, Trachea transplant, Tracheostomy, Transnasal esophagoscopy, Transnasal pituitary surgery, Transoral laser microsurgery, Transoral robotic surgery, Turbinate surgery, Ultrasound-guided fine-needle aspiration, Ultrasound-guided surgery, Upper airway stimulation therapy (Inspire device), Uvulopalatopharyngoplasty (UPPP), Vestibular rehabilitation, Vestibular testing, Videofluoroscopic swallowing study, Video laryngoscopy, Vocal cord injection, Voice therapy.
- A history of Diabetes.
- A history of Hyperthyroidism.
- A history of heart failure
- Younger than 20 years old or older than 75 years old.
- Damaged oral mucosa or lips.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Currently, there are limited studies performed on the treatment of perioperative thirst and the methods provided by literature possess a risk of choking. In addition, there is no good treatment nor relevant research in the area of perioperative thirst in Taiwan. As a result, this study aims to use a visual analogue scale (VAS) as the assessment tool to show that oral spray can significantly ease the thirst-related discomfort for patients recovering from anesthesia, thereby reducing the frequency of painkiller use. This would result in lower labor and material costs, achieving the effect of improved perioperative care quality and cost reduction. It is hoped that in the future, the study can be applied in practice and academic studies to reduce perioperative thirst for patients. Using patients with perioperative thirst in the recovery room as the subject, this study planned to have research personnel or part-timers collect data from a total of 200 patients. Statistical analysis would be performed for data collected from the recovery room.
Read the detailed description
Research design and research subjects use surveymonkey's sample number calculator to set the total number of patients in the year before inclusion and exclusion as the mother population: 5600, the verification power is set to 0.8, the effect is set to 5%, and the estimated sample number needs to be at least 160 patient. The admission process is shown in Figure 1. After the patient reports in the operation registration area, the admission officer randomly selects at least 3 non-head and neck surgery patients every day (see the inclusion and exclusion conditions for details), and gives written and verbal explanations, and obtains informed consent and Signing the consent form, deducting the number of samples lost (for example, the lips are broken due to the intraoperative intubation process or the VAS thirst assessment form score is less than 4 points), and it is estimated that a total of 300 patients will be enrolled. After the patients enter the recovery room, those eligible for inclusion are divided into the control group, the oral spray group and the control group, the oral spray group and the control group, after the sample is lost, it is expected that each group will receive 100 patients. Inclusion conditions: VAS thirst assessment form score ≥ 4 points, age 20-75 years old, anesthesia risk assessment grade ASA: I~III, conscious (GCS: 15 points), Muscle power ≥ 4 points, anesthesia recovery score Aldrate score ≥8 points, informed consent. Excluded conditions: Those who have undergone head and neck surgery this time or have a history of head and neck surgery, have diabetes, hyperthyroidism, a history of heart failure, are younger than 20 years old or older than 75 years old, or have broken oral mucosa or lips.
Research tools: 30ml small-capacity spray bottle, oral cotton swab, sterile distilled water, VAS thirst visual assessment form.
Steps of the study: After entering the recovery room, the patients who meet the criteria for inclusion are divided into the control group, the oral spray group (singular) and the control group, the cotton swab moisturizing the mouth group using random random number generators (minimum 1, maximum 10) (Double number), after the patient wakes up (Aldrate score ≥ 8 points), VAS thirst visual assessment scale score ≥ 4 points, immediately intervene. The control group poured sterile distilled water into a 30ml small-capacity spray bottle and sprayed it on the patient's mouth 4 times, respectively on the oral tongue and under the tongue, the left side and the right side of the mouth. The dose and intensity of the spray were the same; the control group used an oral cotton swab to moisten the oral cavity with sterile distilled water. Before the first intervention and before being transferred out of the recovery room, the VAS Thirst Assessment Form was used to score a total of 2 assessments. In addition, retrospective statistics.
- Conditions
- Anesthesia and Thirst
- Being tested
- oral spry, Cotton swab
- Keywords
- thirst and oral spray and after anesthesia and recovery room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral spryOther
Pour sterile distilled water into a 30ml small-capacity spray bottle and spray 4 times at the patient's mouth. They are on the tongue and under the tongue, the left side and the right side of the mouth. The same spray bottle is used by the same person. Consistent dosage and strength.
Cotton swabOther
Moisten the mouth with sterile distilled water with an oral cotton swab.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Pour sterile distilled water into a 30ml small-capacity spray bottle and spray 4 times at the patient's mouth. They are on the tongue and under the tongue, the left side and the right side of the mouth. The same spray bottle is used by the same person. Consistent dosage and strength Receives: Other: oral spry |
| contrast group | Other | Moisten the mouth with sterile distilled water with an oral cotton swab. Receives: Other: Cotton swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of Thirst Assessment( minimum values: 0, maximum values: 10)
Before the first intervention and before being transferred out of the recovery room, use the Visual Analogue Scale of Thirst Assessment( minimum values: 0, maximum values: 10) Form to score a total of 2 times.
Measured: 1hour
Secondary outcomes (1)
Number of painkillers used
In addition, retrospective statistics were used to determine whether there was a difference in the number of thirst interventions and the number of painkillers used between the two groups of patients.
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start10 Feb 2022
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia and ThirstStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ChingWen Cheng, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172648
- Sponsor's protocol ID
- 202104124RINC
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Small-volume Oral Spray in the After Anesthesia Recovery Room for Thirst Patients
- ClinicalTrials.gov ID
- NCT05172648
- Acronym / sponsor ID
- 202104124RINC
- Conditions
- Anesthesia and Thirst
- Keywords
- thirst and oral spray and after anesthesia and recovery room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there are limited studies performed on the treatment of perioperative thirst and the methods provided by literature possess a risk of choking. In addition, there is no good treatment nor relevant research in the area of perioperative thirst in Taiwan. As a result, this study aims to use a visual analogue scale (VAS) as the assessment tool to show that oral spray can significantly ease the thirst-related discomfort for patients recovering from anesthesia, thereby reducing the frequency of painkiller use. This would result in lower labor and material costs, achieving the effect of improved perioperative care quality and cost reduction. It is hoped that in the future, the study can be applied in practice and academic studies to reduce perioperative thirst for patients. Using patients with perioperative thirst in the recovery room as the subject, this study planned to have research personnel or part-timers collect data from a total of 200 patients. Statistical analysis would be performed for data collected from the recovery room.
Detailed description
Research design and research subjects use surveymonkey's sample number calculator to set the total number of patients in the year before inclusion and exclusion as the mother population: 5600, the verification power is set to 0.8, the effect is set to 5%, and the estimated sample number needs to be at least 160 patient. The admission process is shown in Figure 1. After the patient reports in the operation registration area, the admission officer randomly selects at least 3 non-head and neck surgery patients every day (see the inclusion and exclusion conditions for details), and gives written and verbal explanations, and obtains informed consent and Signing the consent form, deducting the number of samples lost (for example, the lips are broken due to the intraoperative intubation process or the VAS thirst assessment form score is less than 4 points), and it is estimated that a total of 300 patients will be enrolled. After the patients enter the recovery room, those eligible for inclusion are divided into the control group, the oral spray group and the control group, the oral spray group and the control group, after the sample is lost, it is expected that each group will receive 100 patients. Inclusion conditions: VAS thirst assessment form score ≥ 4 points, age 20-75 years old, anesthesia risk assessment grade ASA: I~III, conscious (GCS: 15 points), Muscle power ≥ 4 points, anesthesia recovery score Aldrate score ≥8 points, informed consent. Excluded conditions: Those who have undergone head and neck surgery this time or have a history of head and neck surgery, have diabetes, hyperthyroidism, a history of heart failure, are younger than 20 years old or older than 75 years old, or have broken oral mucosa or lips.
Research tools: 30ml small-capacity spray bottle, oral cotton swab, sterile distilled water, VAS thirst visual assessment form.
Steps of the study: After entering the recovery room, the patients who meet the criteria for inclusion are divided into the control group, the oral spray group (singular) and the control group, the cotton swab moisturizing the mouth group using random random number generators (minimum 1, maximum 10) (Double number), after the patient wakes up (Aldrate score ≥ 8 points), VAS thirst visual assessment scale score ≥ 4 points, immediately intervene. The control group poured sterile distilled water into a 30ml small-capacity spray bottle and sprayed it on the patient's mouth 4 times, respectively on the oral tongue and under the tongue, the left side and the right side of the mouth. The dose and intensity of the spray were the same; the control group used an oral cotton swab to moisten the oral cavity with sterile distilled water. Before the first intervention and before being transferred out of the recovery room, the VAS Thirst Assessment Form was used to score a total of 2 assessments. In addition, retrospective statistics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: oral spryPour sterile distilled water into a 30ml small-capacity spray bottle and spray 4 times at the patient's mouth. They are on the tongue and under the tongue, the left side and the right side of the mouth. The same spray bottle is used by the same person. Consistent dosage and strength |
| contrast group | Other | Other: Cotton swabMoisten the mouth with sterile distilled water with an oral cotton swab. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- VAS thirst assessment form score ≥ 4 points
- Age 20-75 years old
- Anesthesia risk assessment grade Amersican Society of Anesthesiologists: I~III:The first level (ASAⅠ)-healthy people, except for surgical corrections, without any systemic disease patients, such as patients with simple appendicitis (pre- and post-operative mortality rate 0.06~0.08%); Level 2 (ASAⅡ)-Patients with mild systemic disease but no functional impairment, such as those over 70 years old without any disease, or a small cold, HTN or DM but well-controlled diseases (pre- and post-operative mortality 0.27~0.4%); Level III (ASAⅢ)-Moderate to severe systemic disease and cause partial dysfunction, such as HTN or DM but not well controlled, or have cardiovascular complications (stroke, myocardial infarction, angina, etc.) (The mortality rate before and after surgery is 1.8~4.3%).
- Conscious (GCS: 15 points).
- Muscle power ≥ 4 points.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral spryPour sterile distilled water into a 30ml small-capacity spray bottle and spray 4 times at the patient's mouth. They are on the tongue and under the tongue, the left side and the right side of the mouth. The same spray bottle is used by the same person. Consistent dosage and strength. | Other | control group |
| Cotton swabMoisten the mouth with sterile distilled water with an oral cotton swab. | Other | contrast group |
Primary outcome
Visual Analogue Scale of Thirst Assessment( minimum values: 0, maximum values: 10)
Time frame: 1hour
Before the first intervention and before being transferred out of the recovery room, use the Visual Analogue Scale of Thirst Assessment( minimum values: 0, maximum values: 10) Form to score a total of 2 times.
1 secondary outcome
Number of painkillers used
Time frame: 1hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChingWen Cheng, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral spry and Cotton swab in people with Anesthesia and Thirst, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of Thirst Assessment( minimum values: 0, maximum values: 10) (time frame: 1hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.