The effect of 30 mg oral dextromethorphan and placebo on postoperative analgesia after laparoscopic cholecystectomy
Design
114 patients undergoing laparoscopic cholecystectomy in a double-blind randomized clinical trial were randomly divided into either intervention( 30 mg or 10 cc of dextromethorphan syrup 2 hours before induction of anesthesia used) or control groups(10 cc of a neutral syrup is taken orally.).
Settings and conduct
In this study, patients olde candidate for laparoscopic cholecystectomy surgery who will be referred to the Besat Hospital of Hamadan during the study period, will be randomly assigned to randomized allocation blocks by random sampling.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with ASA class 1 and 2; Patients candidate for laparoscopic cholecystectomy. Exclusion Criteria: Patients with systemic underlying disease; Patients with history of alcohol and drug use, sedation and anticonvulsants; History sensitivity to drugs
Intervention groups
Intervention group: 30 mg or 10 cc of dextromethorphan syrup 2 hours before induction of anesthesia used.
Control: 10 cc of a neutral syrup is taken orally.
Main outcome variables
Pain score using VAS, Systolic and Diastolic Blood Pressure, Nausea & vomiting, Heart Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170603034303N3
Registration date:2019-08-28, 1398/06/06
Registration timing:registered_while_recruiting
Last update:2019-08-28, 1398/06/06
Update count:0
Registration date
2019-08-28, 1398/06/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 6955
Email address
m.rezaeei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 30 mg oral dextromethorphan and placebo on postoperative analgesia after laparoscopic cholecystectomy at the Hamedan Besat hospital
Public title
The effect of 30 mg oral dextromethorphan and placebo on postoperative analgesia after laparoscopic cholecystectomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA class 1 and 2
Patients candidate for laparoscopic cholecystectomy
Exclusion criteria:
Patients with systemic underlying disease
Patients with history of alcohol and drug use, sedation and anticonvulsants
History sensitivity to drugs
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and, According to the text, the patient is given one of two groups: A (Intervention) and B Control). Then, for four subsequent patients, the paper is returned to the bag again, and this process is repeated until the end of the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
In both groups A and B, medications after spinal anesthesia Medication or placebo will be prescribed.In order to prevent the medication being detectable for patients and investigators, they are prepared with same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-08-10, 1398/05/19
Ethics committee reference number
IR.UMSHA.REC.1398.430
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis
Primary outcomes
1
Description
Pain
Timepoint
1, 6 and 12 hours after surgery
Method of measurement
VAS score
Secondary outcomes
1
Description
Nausea & vomiting
Timepoint
After surgery
Method of measurement
Observation
2
Description
Systolic and Diastolic Blood Pressure
Timepoint
1 hours after surgery
Method of measurement
Barometer
3
Description
Heart Rate
Timepoint
1 hours after surgery
Method of measurement
Using a pulse oximeter
Intervention groups
1
Description
Intervention group: 30 mg or 10 cc of dextromethorphan syrup 2 hours before induction of anesthesia used
Category
Treatment - Drugs
2
Description
Control group: 10 cc of a neutral syrup 2 hours before induction of anesthesia used orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Mahmoud Rezaeei, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Besat Hospital in Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
m.rezaeei@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ِDr Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahmoud Rezaeei
Position
Assistant Professor of Hamadan University Of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Besat Hospital in Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
m.rezaeei@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahmoud Rezaeei
Position
Assistant Professor of Hamadan University Of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Besat Hospital in Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
m.rezaeei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahmoud Rezaeei
Position
Assistant Professor of Hamadan University Of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Besat Hospital in Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
m.rezaeei@umsha.ac.ir
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