Dexmedetomidine and Laparoscopic Surgery

Anesthesia Complication Clinical Trial

Official title:

The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172065
• Other study ID #: IDGL
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 9, 2018

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 9, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Elective gynaecological laparoscopic surgery

• Age 20-45 yrs

• Suspected surgery time 30 minutes

• Inflation pressure <13 Cm H20

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia Complication

Intervention

Drug:
• Normal saline
intravenous flluid
• Dexmedetomidine
anaesthetic adjuvants and pain killer medication.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence shoulder tip pain		48 hours
Secondary	intraoperative haemodynamic stability, et co2, sao2.		2 hours