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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037103
Receipt No. R000042281
Scientific Title Use of Pregabalin for attenuation of hemodymanic response to laryngoscopy and intubation in treated hypertensive patients
Date of disclosure of the study information 2019/06/19
Last modified on 2020/07/03

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Basic information
Public title Use of Pregabalin for attenuation of hemodymanic response to laryngoscopy and intubation in treated hypertensive patients

Acronym Use of Pregabalin for attenuation of hemodymanic response to laryngoscopy and intubation in treated hypertensive patients

Scientific Title Use of Pregabalin for attenuation of hemodymanic response to laryngoscopy and intubation in treated hypertensive patients

Scientific Title:Acronym Use of Pregabalin for attenuation of hemodymanic response to laryngoscopy and intubation in treated hypertensive patients

Region
Asia(except Japan)

Condition
Condition premptive pregabalin in hypertensive patient
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To look the response of preemptive Pregabalin in attenuating the hemodynamic response to laryngoscopy and intubation in treated hypertensive patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response of preemptive Pregabalin in attenuating the hemodynamic response to laryngoscopy and intubation in treated hypertensive patients.
Key secondary outcomes 1. pre-operative anxiety level
2. heart rate
3. systolic and diastolic pressure.
4. mean arterial pressure.
5. side effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 A thorough pre-anaesthetic assessment and investigations will be performed before patient selection. An informed written consent will be taken in all the patients. All the patients will be pre-medicated with tab Dizepam 5 mg a night before surgery. All 50 enrolled patients will be randomized to one of the two oral premedication treatment groups of 25 patients each.Group II will recieve Cap. Pregabalin (75 mg), given with sips of water 60 minutes before induction of general anesthesia.
Interventions/Control_2 Group I will receive placebo (Vitamin b/c)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Scheduled for elective surgery under general anesthesia .
2. All patients with controlled hypertension.
3. All patients of ASA physical status II.
4. Patient aged 30-70 years.
Key exclusion criteria 1. Unwilling patients.
2. Patients with ASA grade III or higher.
3. Pre-existing cardiac disease, asthma, and severe renal or hepatic dysfunction.
4. Anticipated difficult intubation.
5. Patients with morbid obesity.
6. History of taking antidepressants drugs.

Target sample size 50

Research contact person
Name of lead principal investigator
1st name Puja
Middle name
Last name Thapa
Organization Nepalese Army Institute Of Health Sciences
Division name Bagmati
Zip code 44600
Address Chhauni,Kathmandu
TEL +9779851152449
Email thapa_puza@yahoo.com

Public contact
Name of contact person
1st name Puja
Middle name
Last name Thapa
Organization Nepalese Army Institute of Health Sciences
Division name Bagmati
Zip code 44600
Address Chhauni, Kathmandu
TEL 009779851152449
Homepage URL http://naihs.edu.np/
Email thapa_puza@yahoo.com

Sponsor
Institute Nepalese Army Institute of Health Sciences.
Institute
Department

Funding Source
Organization Nepalese Army Institute of Health Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nepalese Army Institute of Health Sciences
Address Sanobharyang, kathmandu
Tel +977-1-4881259
Email info@naihs.edu.np

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 19 Day

Related information
URL releasing protocol NA
Publication of results Published

Result
URL related to results and publications https://www.nepjol.info/index.php/nmj/article/view/25715
Number of participants that the trial has enrolled 50
Results
 A total of 50 patients, 25 in each arm were enrolled. The baseline characteristics were comparable. SBP was significantly lower in the Pregabalin group than in Placebo at all the periods of recording, however, DBP and MAP decreased significantly during, after 1 and 3 minutes of laryngoscopy (p=0.001). Sedation was significantly better in the Pregabalin group with 86% in RSS 3 compared to 80% of a placebo arm in RSS2 (P <0.001).
Results date posted
2020 Year 07 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Both arms have similar baseline characteristics and they do not differ . 
Participant flow
Randomized into two groups
Adverse events
None observed
Outcome measures
 Intraoperatively, the heart rate, 
MAP, electrocardiography, pulse oximeter (SpO2) and EtCO2 
levels were continuously monitored and recorded before and 
during induction, during laryngoscopy and 1, 3 and 5 min after 
intubation.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 15 Day
Date of IRB
2018 Year 03 Month 01 Day
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 19 Day
Last modified on
2020 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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