This prospective, randomized, double-blind, placebo-controlled study evaluated the effect of dexamethasone and granisetron for reducing the incidence and severity of propofol injection pain.
Inclusion criteria: physical status class I and II from the perspective of America society of Anesthesiologists; dilatation and curettage surgery; 20 to 50 years old
Exclusion criteria: Patients with a history of Allergies to propofol or 5-hydroxytryptamine receptor antagonists or dexamethasone; Patients who received any medication for analgesia or sedation in the past 24 hours; Severe mental disorders; Neuromuscular disease; ischemic heart disease; Uncontrolled hypertension; Renal and hepatic disease; Convulsion disease; Body mass index over 30; Chronic use of any drugs; Gastrointestinal disorders; History of osteoporosis; History of diabetes
One hundred forty one female subjects received 5 mL of preservative-free saline, 1 mg granisetron (mL 5 ml) or 0.15 mg · kg (-1) of dexamethasone (5 ml), intravenously, following exsanguination and occlusion of the veins of the arm. This was followed by a 0.5 mg · kg (-1) injection of propofol. Pain scores, facial grimacing, arm withdrawal, and vocalization were recorded immediately following the injection of propofol. Hemodynamic parameters and o2sat were recorded 1, 3, 5 and 10 minutes after propofol injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040427677N6
Registration date:2017-05-10, 1396/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Urmia University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of granisetron and dexamethasone on intravenous propofol pain
Public title
Clinical trial the effect of granisetron and dexamethasone on intravenous propofol pain in patient whit dilatation and curettage surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: physical status class I and II from the perspective of America society of Anesthesiologists; dilatation and curettage surgery; 20 to 50 years old
Exclusion criteria: Patients with a history of Allergies to propofol or 5-hydroxytryptamine receptor antagonists or dexamethasone; Patients who received any medication for analgesia or sedation in the past 24 hours; Severe mental disorders; Neuromuscular disease; ischemic heart disease; Uncontrolled hypertension; Renal and hepatic disease; Convulsion disease; Body mass index over 30; Chronic use of any drugs; Gastrointestinal disorders; History of osteoporosis; History of diabetes
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
141
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be divided into three groups by random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Emergent Street, Ershad Avenue
City
Urmia
Postal code
5714783734
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
ir.umsu.rec.1394.305
Health conditions studied
1
Description of health condition studied
Pain of propofol injection
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS
Primary outcomes
1
Description
Pain of propofol injection
Timepoint
Induction of Anesthesia
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Mean pulse Rate
Timepoint
Before injection, 1, 3, 5, 10 minutes after injection
Method of measurement
Electrocardiogram
2
Description
Mean Arterial Blood Pressure
Timepoint
Before injection, 1, 3, 5, 10 minutes after injection
Method of measurement
None Invasive Blood Pressure
3
Description
os saturation
Timepoint
Before injection, 1, 3, 5, 10 minutes after injection
Method of measurement
Pulse Oximetry
Intervention groups
1
Description
Intervention group 2: Dexamethasone will be prepared in 5 cc syringes and after closing cord randomly injected.
Category
Treatment - Drugs
2
Description
Intervention group 1: Granisetron will be prepared in 5 cc syringes randomly injected.
Category
Treatment - Drugs
3
Description
Control group: Normal Saline will be prepared in 5 cc syringes randomly injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Shahryar Sane
Street address
Kashani Avenue
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Street address
Emergent Street, Resalat avenue, Urmia
City
Urmia
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 of Urmia University of Medical Sciences