NCT04779060

Brief Summary

Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

4.2 years

First QC Date

February 27, 2021

Last Update Submit

March 15, 2021

Conditions

Intraoperativ Pain

Outcome Measures

Primary Outcomes (1)

  • intraoperative pain

    pain measured by VAS score =from 0 to 10 0-3 is mild pain 3-6 moderate pain 6-10 sever pain

    60 minutes

Study Arms (3)

fentanyle group

ACTIVE COMPARATOR
Drug: intrathecal fentanyle

dexamethasone group

ACTIVE COMPARATOR
Drug: dexamethasone

control group

PLACEBO COMPARATOR
Drug: saline

Interventions

intrathecal fentanyleDRUG

25 mic fentanyle added to heavy bupivacaine for spinal anesthesia

fentanyle group
dexamethasoneDRUG

8 mg dexamethasone give intrathecally for spinal anaesthesia

dexamethasone group
salineDRUG

normal saline will be mixed with bupivacaine intrathecally

control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I, II
  • elective gynacological laparoscopic surgery

You may not qualify if:

  • patient refusal
  • chronic kidney and hepatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

DexamethasoneSodium Chloride

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 3, 2021

Study Start

July 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

EG(1)