Protocol summary

Summary
In the present study we want to investigate the analgesic effects of vitamin C in the patients who undergo UPPP and tonsillectomy. Objectives: 1- To determine and compare the mean pain scores during the first 24 hours after the surgery in both groups. 2- To determine and compare the mean of the systolic, diastolic and arterial blood pressure and the mean heart rate during and after the surgery in both groups. 3- To determine and compare the time interval between the completion of the surgery and the first request for analgesic in both groups . Design: A Phase I or II, Single-Center, Randomized, Double-Blinded, Placebo-Controlled, clinical trial. Setting and conduction: Frothy patients who undergo uvulo-palato-pharyngoplasty and tonsillectomy are randomly divided into two groups by anesthesiologist. The patients are not aware of their groups. For all patients anesthesia induction and maintenance are similar. During the surgery, group C receives vitamin C and group P receives normal saline by anesthesiologist. An anesthesia resident, unaware of the patient’s group, fills out the questionnaires. Finally we will analyze the data with a statistical software. Participants: Patients with age of 25-50 years old, ASA (American Society of Anesthesia) physical status I or II ,who are going to have a UPPP and tonsillectomy, are included .Patients with mental retardation, epilepsy, BMI>35 kg/m2, history of chronic pain, liver or renal disease, drug allergy and drug abuse are excluded from the study. Intervention: During the first 30 minutes after the beginning of the surgery, group C receives infusion of 3 gr vitamin C in 500 ml Ringer and group P receives 5 ml normal saline in 500 ml Ringer. Main outcome measures: 1- Post operative pain 2- Heart rate 3- Systolic, diastolic and mean arterial blood pressure 4- Time of the first analgesic request

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404055764N3
Registration date: 2015-02-15, 1393/11/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Vida Ayatollahi
Name of organization / entity
Shahid Sadughi University
Country
Iran (Islamic Republic of)
Phone
+98 35 1821 5730
Email address
ayatt.vida@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadughi medical science university
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-03-04, 1392/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous vitamin c on post operative pain in uvulopalatopharyngoplasty (uppp) with tonsillectomy.
Public title
Effect of intravenous vitamin c on post operative pain.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 25-50 years; both male and female; BMI<35; American Society of Anesthesia (ASA) physical status I or II; underwent uvulopharyngopalatoplasty with tonsillectomy. Exclution criteria: mental retardation; epilepsy; chronic pain; liver or renal disease; drug abuse and drug allergy.
Age
From 25 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Medical Mniversity Shahid Sadoughi
Street address
Shahid Sadoughi Medical sciences university, Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2012-06-30, 1391/04/10
Ethics committee reference number
28200

Health conditions studied

1

Description of health condition studied
The effect of vitamin c on uvulopharyngopalatoplasty and tonsillectomy pain
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics

Primary outcomes

1

Description
Post operative pain
Timepoint
Recovery room, 6, 12 and 24 hours post operation
Method of measurement
VAS score

Secondary outcomes

1

Description
Systolic, Diastolic and Mean blood pressure
Timepoint
Before and during anesthesia, 0,15, 30 and 60 minute after extubation
Method of measurement
mm Hg by Automatic non invasive blood pressure

2

Description
Heart rate
Timepoint
Before and during anesthesia, 0,15, 30 and 60 minute after extubation
Method of measurement
Before and during anesthesia, 0,15, 30 and 60 minute after extubation

3

Description
Time of the first analgesic request
Timepoint
Hours postoperation
Method of measurement
Recovery room and ward

Intervention groups

1

Description
During the first 30 minute after the beginning of the surgery, patients received infusion of 5ml normal salin in 500 ml ringer
Category
Prevention

2

Description
During the first 30 minute after the beginning of the surgery, patients received infusion of 3 gr vitamin c in 500 ml ringer.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
DR Ayatollahi Vida
Street address
No 12,Shahid Sadoughi Hospital, Ebnesina Street
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of shahid sadoughi medical sciences
Full name of responsible person
DR Mozaffari Hasan
Street address
Shahid Sadoughi medical sciences university, Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of shahid sadoughi medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadoughi Medical sciences university
Full name of responsible person
Dr Ayatollahi Vida
Position
Associate Professor, Anesthesiologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Ebnesina Street
City
Yazd
Postal code
8915887857
Phone
+98 35 3822 4001
Fax
Email
ayatt.vida@ssu.ac.ir؛ ayati.vida @yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi Medical sciences university
Full name of responsible person
DR Ayatollahi Vida
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
No 12, Shahid sadoughi Hospital, Ebnesina Street
City
Yazd
Postal code
Phone
+98 35 3822 4001
Fax
Email
ayatt.vida@ssu.ac.ir; ayati.vida @yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi Medical sciences university
Full name of responsible person
Dr Ayatollahi Vida
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
No 12, Shahid Sadoughi Hospital, Ebnesina Street
City
Yazd
Postal code
8915887857
Phone
+98 35 3822 4001
Fax
Email
ayatt.vida@ssu.ac.ir; ayati.vida @yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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