Protocol summary

Study aim
Determination of the effect of two doses of dexmedetomidine on the prevention of nausea and vomiting in discectomy under spinal anesthesia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 135 patients. Randomization was performed by individual block method using a table of random numbers.
Settings and conduct
This is a double-blind clinical trial that was performed on 135 patients undergoing spinal anesthesia Discectomy in Al-Zahra Hospital in Isfahan in 1398-99. After the approval of the university ethics committee and obtaining the patients' consent, the patients entered the groups by block random allocation. In each group, after spinal anesthesia, the desired intervention was applied and the patient's vital signs were measured and recorded. The clinical caregiver was different from the person injecting the drug and was unaware of the type of intervention being performed. The surgeon and the patient were also unaware of the intervention and were therefore blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18 to 60 years old who are candidates for Discectomy under spinal anesthesia with ASA class 1 and 2. Exclusion criteria: history of cardiovascular disease, fever, obesity, pregnancy, Allergy to Dexmedetomidine , drug interaction with Dexmedetomidine
Intervention groups
Intervention group D1: 0.2 Micrograms per kilogram of body weight per hour of Dexmedetomidine brought to 10 cc by normal saline Intervention group D2: Dose of 0.5 Micrograms per kilogram of body weight per hour of Dexmedetomidine brought to 10 cc by normal saline Control group C: amount of 10 ml of normal saline, After spinal anesthesia and placing the patient in the desired position, it was received as an intravenous infusion pump for 10 minutes.
Main outcome variables
Nausea and vomiting due to dexmedetomidine injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N35
Registration date: 2021-09-06, 1400/06/15
Registration timing: retrospective

Last update: 2021-09-06, 1400/06/15
Update count: 0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
2019-06-30, 1398/04/09
Actual recruitment end date
2020-03-20, 1399/01/01
Trial completion date
2021-05-22, 1400/03/01
Scientific title
Comparison of the effectiveness of two different doses of Dexmedetomidine on the prevention of nausea and vomiting in Discectomy under spinal anesthesia
Public title
The effect of Dexmedetomidine on nausea and vomiting in Discectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 60 years Candidate for Discectomy under spinal anesthesia Grade 1 and 2 Anesthesia Based on American Society Anesthesia Criteria
Exclusion criteria:
History of cardiovascular, respiratory, neurological, endocrine, thyroid, neuromuscular diseases, dysautonomia Fever Obesity (BMI> 27) History of vasoactive drugs, MAOI and TCA History of drug use Allergy to Pethidine, Ketamine and Magnesium sulfate Pregnancy Allergy to Dexmedetomidine Taking drugs with drug interactions with Dexmedetomidine
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 135
Actual sample size reached: 135
Randomization (investigator's opinion)
Randomized
Randomization description
This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs and placebo are placed in the desired number in sealed opaque and uniform sealed envelopes. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This was a double-blind controlled clinical trial in which the patient and the evaluator had no known information about the type and dose of the drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.MUI.MED.REC.1398.173

Health conditions studied

1

Description of health condition studied
Nausea and vomiting due to Discectomy under spinal anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nausea and vomiting due to dexmedetomidine injection
Timepoint
Immediately after spinal up to 24 hours after surgery
Method of measurement
Use Visual Analogue Scale or VAS

Secondary outcomes

1

Description
Heart Rate
Timepoint
Immediately after spinal up to 24 hours after surgery
Method of measurement
ECG monitoring

2

Description
Systolic blood pressure
Timepoint
Immediately after spinal up to 24 hours after surgery
Method of measurement
Barometer

3

Description
Diastolic blood pressure
Timepoint
Immediately after spinal up to 24 hours after surgery
Method of measurement
Barometer

4

Description
Arterial blood oxygen saturation
Timepoint
Immediately after spinal up to 24 hours after surgery
Method of measurement
Pulse oximeter

Intervention groups

1

Description
Intervention group D1: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia and dexmedetomidine injection, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then 0.2 micrograms per kilogram of body weight per hour Dexmedetomidine made in Germany, which was increased to 10cc by normal saline, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery.
Category
Prevention

2

Description
Intervention group D2: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia and dexmedetomidine injection, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then 0.5 micrograms per kilogram of body weight per hour Dexmedetomidine made in Germany, which was increased to 10cc by normal saline, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery.
Category
Prevention

3

Description
Control group C: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then, 10cc of normal saline made by Saha Med Company, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Negar Khan ahmad
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazem roaya
Position
Professor assistant of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leyla Rafiei
Position
Nurse Anesthesia
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
leylarafiei943@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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