Comprasion of Effectiveness Oxycodone Pills and Pethidine Ampoule in Control of Patient’s Shivering after Ingueinal Hernioraphy followed by Spinal Anesthesia
The aim of this study was to compare the efficacy of oxycodone and pethidine ampoule in control of shivering in patients undergoing spinal anaesthesia herniorrhaphy.
Design
A randomized controlled trial clinical trial with cross-over, double-blind, placebo
Settings and conduct
The study population consisted of patients with chills in recovery and operating room of Fatemi and Imam Khomeini hospitals in Ardabil. There will be two types of envelopes: Envelope A with pethidine syringe and placebo tablets, and Envelope B with syringes containing normal saline and oxy codon. Each disease will receive these envelopes depending on whether they have A or B code. The drug is prescribed before surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria include ASA I, II patients with post-spinal anaesthesia shivering with inguinal hernia diagnosis. Exclusion criteria included the history of pethidine or oxycodone sensitivity, history of peptic ulcer, systemic infection or immunodeficiency, history of use of monoamine oxidase inhibitor drugs, untreated hypothyroidism, benign prostatic hypertrophy, sickle cell disease, Addison They had significant bleeding during surgery and patients who did not undergo spinal anesthesia and became anesthetized.
Intervention groups
Pethidine ampoule will be given 0.4 mg/kg immediately after spinal anesthesia and 5 mg oxycodone tablet half an hour before surgery.
Main outcome variables
The incidence and severity of shivering will be assessed during and after surgery and their shivering score will be recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041248N1
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2020-01-05, 1398/10/15
Update count:0
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Saman Hayadokht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 2521
Email address
s.hayadokht@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-30, 1398/03/09
Expected recruitment end date
2020-01-29, 1398/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion of Effectiveness Oxycodone Pills and Pethidine Ampoule in Control of Patient’s Shivering after Ingueinal Hernioraphy followed by Spinal Anesthesia
Public title
Evaluation of the Effect of Oxycodone Pills on Shivering Control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients ASA I,II
Patients who have been diagnosed with Inguinal Hernia after Spinal Anesthesia and have been Shivering
Exclusion criteria:
History of Allergy to Pethidine or Oxycodone
History of Peptic Ulcer, Systemic Infection, or Immune Deficiency
History of Taking MAO Inhibitors
Untreated Hypothyroidism
Benign Prostatic Hypertrophy
Addison Diseases
Uterine Stenosis
Seizure Disorders
Patients who have had Significant Bleeding during Surgery
Patients who do not have Spinal Anesthesia and become ansthetized
Under 18 years of age
over 65 years old
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be prepared randomly assigned in two Groups: Pethidine and Oxycodone. This is two blinded study. Each morning before surgery, the Number of Surgeries and the Number of Medications required by the Prescriber will be Available.There will be two Envelopes. Case A has Pethidine and Placebo Pills and the Envelope B contains a Syringe containing Normal Saline and an Oxycodone Pill. Any Disease based on the Code A or B they will receive these Envelopes. The Prescription is prescribed before Surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
This Study is a Double Blind Clinical Trial. In this Study, 110 Patients were diagnosed with Inguinal Hernia for Random Allocation of Pethidine and Oxycodone each Day before Surgery the Number of Surgeries and the Number of required by the Presenter the Plan will be ready. There will be two types of Envelopes. Case A has Pethidine and Placebo Pills and the Envelope B contains a Syringe containing Normal Saline and an Oxycodone Pill. Any Disease based on the Code A or B they will receive these Envelopes. The Prescription is prescribed before Surgery.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil, Azadegan Town, Second Block, Second Alley
City
Ardabil
Province
Ardabil
Postal code
53141-56198
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.ARUMS.REC.1396.158
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
T 88.5
ICD-10 code description
Other complication of anesthesia
Primary outcomes
1
Description
Incidence of shivering during surgery and after surgery
Timepoint
During surgery, in recovery and in section
Method of measurement
Observation
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
1, 6, 12 and 24 hour intervals
Method of measurement
Question from the patient
Intervention groups
1
Description
Intervention group: There will be two types of envelopes: Packet A with pethidine syringe and placebo tablets, and B envelope with syringes containing normal saline and oxycodon. Pethidine will be given 0.4 mg / kg immediately after spinal anesthesia and oxycodone 5 mg tablet half an hour before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi and Imam Khomeini Hospitals of Ardabil
Full name of responsible person
Saman Hayadokht
Street address
Emam Khomeini Hospital, Ataii Ave., Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
53141-56198
Phone
+98 45 3323 2520
Email
Emamhe@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ghodrat Akhavan Akbari
Street address
Ardabil University of Medical Sciences, Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
Gh.Akhavanakbari@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Saman Hayadokht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ardebil- Azadegan Town- Second Alley- Second Block-plaque 51
City
Ardabil
Province
Ardabil
Postal code
5617693844
Phone
+98 45 3372 5915
Email
S.Hayadokht@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ghodrat Akhavanakbari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2252
Email
G.Akhavanakbari@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Saman Hayadokht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ardabil - Azadegan Town - Second Alley - Second Block - No. 51
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3372 5915
Email
S.Hayadokht@arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD