Protocol summary

Summary
The aim of this study is compare Dexamethasone-Ketamine ‎‎and ‎Dexmedetomidine to prevent nausea and vomiting during ‎‎and after cesarean ‎section after in spinal anesthesia.This study ‎‎is Double-blind and clinical trial in ‎Taleghani Hospital in Arak. ‎‎Inclusion criteria: single pregnancy; 18 to 35 years; elective ‎‎cesarean section; ASA I and II .Exclusion criteria: general ‎‎‎anesthesia; prescription drugs after delivery; body mass index ‎‎more than 35; ‎motion sickness; intrauterine growth ‎‎retardation; history of anti emetic drugs in ‎‎24 hours before ‎‎nausea and vomiting. ‎Spinal anesthesia performed by ‎‎anesthesiologists . Anesthesiologists divided ‎randomly in 4 ‎‎equal groups (each group 40 person). We injected 20 ‎milliliter ‎normal saline in first group. We injected 8 milligram of ‎‎Dexamethasone in 20 ml of normal ‎saline in second group.We ‎injected ‎‎0/5 milligram in Ketamine in 20 milliliter ‎normal saline ‎in 10 minute in third group. We injected 1 micro gram per ‎‎kilogram of Dexmedetomidine in 20 milliliter of ‎normal ‎saline ‎in 10 minute in fourth Group. We recorded Number of nausea, ‎vomiting ‎after clamping the ‎umbilical cord in 4 hours after ‎surgery.We ‎recorded Blood pressure, heart rate ‎and arterial ‎oxygen ‎saturation every 5 minutes to exit recovery. ‎We ‎‎recorded patient satisfaction and total dose of ‎‎Metoclopramide and degree of ‎patient peace in all ‎patients.‎

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016091320258N10
Registration date: 2016-11-08, 1395/08/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University Of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexamethasone- Ketamine and Dexmedetomidine ‎for prevention of postoperative nausea and vomiting during and ‎after cesarean section under spinal anesthesia
Public title
Comparison of Dexamethasone- Ketamine and Dexmedetomidine ‎for prevention of postoperative nausea and vomiting during and ‎after cesarean section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single pregnancy; 18 -35 years; elective cesarean section; ASA ‎I,II Exclusion criteria: general anesthesia; prescription drugs after delivery; body ‎mass index more than 35; motion sickness; Intrauterine growth retardation; ‎history of anti-nausea and vomiting 24 hours before surgery; history of ‎gastrointestinal disease; history of allergy; Nausea and vomiting before ‎clamping the umbilical cord; lack of patient satisfaction.‎
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
848179641
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.ARAKMU.REC.1395.181

Health conditions studied

1

Description of health condition studied
Cesarean
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section

Primary outcomes

1

Description
Nausa and vomitting
Timepoint
After clamping the umbilical cord ‎
Method of measurement
Visual Analogue Scale

2

Description
Blood pressure
Timepoint
Every 5 minute to recovery
Method of measurement
Millimeter Hg

3

Description
Heart rate
Timepoint
Every 5 minute to recovery
Method of measurement
Count

4

Description
Oxygen saturation
Timepoint
Every 5 minute to recovery
Method of measurement
Percent

5

Description
Patient satisfaction ‎
Timepoint
After recovery
Method of measurement
Visual Analogue Scale

6

Description
Total of dose of Metoclopramide
Timepoint
After recovery
Method of measurement
Miligeram

7

Description
Degree of patient peace ‎
Timepoint
Before prescribe to after recovery
Method of measurement
Ramsay Scale‏ ‏

Secondary outcomes

empty

Intervention groups

1

Description
We injected 20‎ milliliter normal saline in first group
Category
Treatment - Drugs

2

Description
We injected 8 milligram of ‎Dexamethasone in 20 ml of normal ‎‎saline in second group.
Category
Treatment - Drugs

3

Description
We injected ‎‎0/5 milligram in Ketamine in 20 milliliter ‎normal ‎saline in 10 minute in third group.
Category
Treatment - Drugs

4

Description
We injected 1 microgram per ‎kilogeram of Dexmedetomidine in ‎‎20 milliliter of ‎normal ‎saline in 10 minute in fourth group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Taleghani hospital, Emam Khomeini street, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Science
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak University of Medical Science
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
Medicine department
Full name of responsible person
Nilufar Shams
Position
Student of medicine
Other areas of specialty/work
Street address
Payambar Azam complex, Basij squre , Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3417 3638
Fax
Email
alikamaliir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Hesamodin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital, Valiasr squre, Shahid Shirodi street, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
alikamaliir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Nilufar Shams
Position
Student of medicine
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
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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