UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037103
Receipt number 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 00:43:24

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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 or person

Institute

Nepalese Army Institute of Health Sciences.

Institute

Department

Personal name



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

Value
https://center6.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