Evaluating the effects of using a single dose of dexamethasone and chlorpheniramine alone and together in the prevention of postoperative nausea and pain in patients undergoing laparoscopic cholecystectomy
The purpose of this study was to evaluate the efficacy of dexamethasone and chlorpheniramine alone and together in prevention of postoperative nausea and pain after laparoscopic cholecystectomy. This single centered double–blinded clinical trial was performed on 100 patients undergoing laparoscopic cholecystectomy. Patients candidate for laparoscopic cholecystectomy were included to the study without age limit if they had written consent. Opium addiction, patients who received antiemetic agents during 24 hrs before the operation and patients who received steroids and antihistamines were excluded from the study. Patients were randomly divided into 4 grouse based on the selected colored cards. Studied interventions in all treatment groups was performed 30 minutes before the surgery. Group 1 received 8 mg of dexamethasone, group 2 received a vial of chlorpheniramine and group 3 received both dexamethasone and chlorpheniramine , and the group 4 received neither drug placebo. The study was double–blinded neither the subjects nor the investigators were aware of the distribution of the drugs. The postoperative pain was recorded from one to ten with visual analogue scale every 2 hrs to 12 hrs after the remove of tracheal tube. Nausea was evaluated as a secondary variable on the basis of scoring criteria. At the end the results of each group was compared to others.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030126853N1
Registration date:2016-05-01, 1395/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Hoda Hekmat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
h.hekmat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of using a single dose of dexamethasone and chlorpheniramine alone and together in the prevention of postoperative nausea and pain in patients undergoing laparoscopic cholecystectomy
Public title
Evaluating the effects of using of dexamethasone and chlorpheniramine in the prevention of postoperative nausea and pain in patients undergoing Laparoscopic Gallbladder Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Undergoing elective surgery laparoscopic cholecystectomy.
Exclusion criteria: Opium addiction; liver disorders; tuberclosis or latent tuberclosis; Hypothyroidism; using Steroids, Antihistamines or Digoxin, Oral contraceptive pill and Amphotericin; diabetes melitus; fungal infections; hyper tension; morbid obesity; the use of antiemetic agents during 24 hrs before surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random sampling is based on the selected colored cards.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
3419759811
Approval date
2016-02-23, 1394/12/04
Ethics committee reference number
IR.QUMS.REC.1394.277
Health conditions studied
1
Description of health condition studied
Nausea & Vomiting , Following laparoscopic cholecystectomy
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
pain
Timepoint
Every 2 to 12 hours after the removal of tracheal tube
Method of measurement
based on the visual analogue scales (VAS)
Secondary outcomes
1
Description
Nausea
Timepoint
Every 2 to 12 hours after the removal of tracheal tube
Method of measurement
Based on observation and scoring criteria
Intervention groups
1
Description
Group 1 received 8 mg of dexamethasone(DarouPakhsh) 30 minutes before the operation.
Category
Prevention
2
Description
Group 2 received a vial of chlorpheniramine (Alborz Darou) 30 minutes before the operation.
Category
Prevention
3
Description
Group 3 received a vial of chlorpheniramine(Alborz Darou) along with 8 mag of dexamethasone(DarouPakhsh) 30 minutes before the operation.