Dexmedetomidine and Laparoscopic Surgery
The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.
1 other identifier
interventional
60
1 country
1
Brief Summary
Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia. The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2018
CompletedAugust 21, 2020
August 1, 2020
1 year
May 23, 2017
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
occurrence shoulder tip pain
48 hours
Secondary Outcomes (1)
intraoperative haemodynamic stability, et co2, sao2.
2 hours
Study Arms (2)
control group
OTHERwill receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline
Dexmedetomidine group
OTHERwill receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)
Interventions
Eligibility Criteria
You may qualify if:
- Elective gynaecological laparoscopic surgery
- Age 20-45 yrs
- Suspected surgery time 30 minutes
- Inflation pressure \<13 Cm H20
You may not qualify if:
- Contraindications to regional block (infection at the needle insertion site)
- Altered conscious level.
- Pregnancy
- Body mass index \>35
- Height \<155 cm
- Patients who have difficulty understanding the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, 71111, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia
Study Record Dates
First Submitted
May 23, 2017
First Posted
June 1, 2017
Study Start
July 1, 2017
Primary Completion
July 5, 2018
Study Completion
July 9, 2018
Last Updated
August 21, 2020
Record last verified: 2020-08