PONV: Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02525848

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

21.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: dexamethasone Drug: Gabapentin Drug: Aprepitant	Phase 2/Phase 3

Detailed Description

Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting.

Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexamethasone intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;	Drug: dexamethasone dexamethasone 8 mg iv 2 minutes before induction of anesthesia Other Names: Decadron
Active Comparator: gapabentin oral gabapentin 600 mg 1 hour before induction of anesthesia	Drug: dexamethasone dexamethasone 8 mg iv 2 minutes before induction of anesthesia Other Names: Decadron Drug: Gabapentin oral gabapentin 600 mg 1 hour before induction of anesthesia Other Names: Neurontin
Active Comparator: Aprepitant aprepitan 80mg 1 hour before induction of anesthesia.	Drug: dexamethasone dexamethasone 8 mg iv 2 minutes before induction of anesthesia Other Names: Decadron Drug: Aprepitant oral aprepitan 80mg 1 hour before induction of anesthesia. Other Names: Emend

Arm

Intervention/Treatment

Active Comparator: dexamethasone

intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;

Drug: dexamethasone

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Other Names:

Decadron

Active Comparator: gapabentin

oral gabapentin 600 mg 1 hour before induction of anesthesia

Drug: dexamethasone

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Other Names:

Decadron

Drug: Gabapentin

oral gabapentin 600 mg 1 hour before induction of anesthesia

Other Names:

Neurontin

Active Comparator: Aprepitant

aprepitan 80mg 1 hour before induction of anesthesia.

Drug: dexamethasone

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Other Names:

Decadron

Drug: Aprepitant

oral aprepitan 80mg 1 hour before induction of anesthesia.

Other Names:

Emend

Outcome Measures

Primary Outcome Measures

incidence (%) of postoperative nausea and vomiting [24 hours postoperative]
The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.

Secondary Outcome Measures

non invasive blood pressure [intra-operative from induction of general anesthesia till end of surgery.]
Noninvasive blood pressure measured immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery
heart rate [Intra-operative from induction of anesthesia till end of surgery.]
heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery
side effects [24 h postoperative.]
Side effects of given drugs will be treated and recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

• ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.

Exclusion Criteria:

Central or peripheral neurological pathologies.
History of drug abuse, chronic pain, or psychiatric disorders.
Pregnant women
Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hala saad Abdel-Ghaffar	Assiut	Assiut governorate	Egypt	715715

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Hala S Abdel-Ghaffar, MD, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt