Postoperative pain management is an important part of postoperative care and plays an important role in postsurgical ambulation and general status of patients. We aim to evaluate the analgesic and sedative effects of preoperative oral dextromethorphan on post operation pain in patients undergoing vitrectomy. In this study, 60 patientsbetween 35 and 75 years old candidate for vitrectomy with ASA class I and II will be randomly assigned to two groups of 30 patients using random blocks. Patients and the person evaluating the outcome would be unaware of the given drug. The exclusion criteria include obese patients, History of opioid consumption within 48 hours of surgery and sedatives or centrally acting drugs 21 days prior to surgery, those with a history of chronic pain, psychotic disorders or addiction including opioids, those with any contraindications to dextromethorphan, and pregnant or lactating women. Before operation, patients will be administered 30 mg dextromethorphan or placebo orally. Pain severity and sedative level will be evaluated immediately after, 1, 2 and 6 hours post surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102510599N21
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of research Iran University of Medical Sciences
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of oral dextromethorphan in acute pain after surgery in patients undergoing vitrectomy
Public title
Evaluating the effects of oral dextromethorphan in acute pain after surgery in patients undergoing vitrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients between 35 to 75 years old; with ASA classes I and II; undergoing vitrectomy under general anesthesia;
Exclusion criteria: Obese patients; History of opioid consumption within 48 hours of surgery; sedatives or centrally acting drugs use (central nervous system depressants or antidepressants) 21 days prior to surgery; those with a history of chronic pain; psychotic disorders or addiction including opioids; those with any contraindications to dextromethorphan; and pregnant or lactating women.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat high way
City
Tehran
Postal code
1449614535
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.IUMS.REC.1395.9211184016
Health conditions studied
1
Description of health condition studied
Disorders of vitreous body
ICD-10 code
H43
ICD-10 code description
Disorders of vitreous body
2
Description of health condition studied
postprocedural pain
ICD-10 code
G89.18
ICD-10 code description
Pain during the period after surgery.
Primary outcomes
1
Description
pain
Timepoint
after surgery in recovery, 1, 2 and 6 hours after surgery
Method of measurement
using visual analogue scale
Secondary outcomes
1
Description
sedation rate
Timepoint
after surgery in recovery, 1, 2 and 6 hours after surgery
Method of measurement
using Ramsy sedation assessment scale
Intervention groups
1
Description
Patients in second group will receive placebo before induction and then undergo general anesthesia
Category
Placebo
2
Description
Patients in group one will receive 30 mg dextromethorphan orally before induction and then undergo general anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Poopak Rahimzadeh
Street address
Rasool Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of research Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Ali Javad Mousavi
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of research Iran University of Medical Sciences
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
Rasool Akram Hospital
Full name of responsible person
Poopak Rahimzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Rasool Akram Hospital, Mansouri st., Niyayesh Ave., Satarkhan St.
City
Tehran
Postal code
1445613131
Phone
+98 21665500499
Fax
Email
P-rahimzadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasool Akram Hospital
Full name of responsible person
Poupak Rahimzadeh
Position
Associate Prof of Aanesthesia
Other areas of specialty/work
Street address
Rasool Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St